Trial Summary
What is the purpose of this trial?This trial is studying methocarbamol, a muscle relaxant, for pain management in patients having ventral or inguinal hernia surgery. Methocarbamol has been used since 1994 as an adjunct for pain management in various surgeries, showing a decrease in postoperative pain and use of intravenous narcotics. The study will compare methocarbamol alone, standard opioid treatment, and a combination of both. The goal is to find out if methocarbamol can effectively reduce pain after surgery.
Is the drug Methocarbamol combined with opioids a promising option for managing hernia pain?Yes, Methocarbamol combined with opioids is promising for managing hernia pain because it can help reduce the amount of opioids needed, which lowers the risk of opioid abuse and misuse.39131415
What data supports the idea that Methocarbamol + Opioids for Hernia Pain Management is an effective drug?The available research does not provide any data specifically supporting the effectiveness of Methocarbamol + Opioids for Hernia Pain Management. The studies mentioned focus on other drugs and treatments for different surgical conditions, such as the use of oxyphenbutazone for postoperative inflammation and various antibiotics for preventing infections in surgeries. Therefore, there is no direct evidence from the provided information to support the effectiveness of Methocarbamol + Opioids for hernia pain.124610
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, chronic opioid users are excluded from participating.
What safety data exists for using Methocarbamol and opioids in hernia pain management?The safety data for using opioids in pain management highlights several potential adverse effects, including opioid-induced respiratory depression, gastrointestinal complications, and histamine release. Opioids are generally safe when side effects are anticipated and managed appropriately. Methocarbamol, a muscle relaxant, is not specifically mentioned in the provided research, but it is often used in combination with other analgesics for pain management. The safety of combining Methocarbamol with opioids would require careful monitoring for drug interactions and side effects. Overall, while opioids are effective for pain relief, their use requires careful consideration of potential adverse effects and patient-specific factors, such as renal or hepatic impairment.5781112
Eligibility Criteria
Adults over 18 undergoing ventral or inguinal hernia repair who consent to randomization can join this trial. It's not for those under 18, pregnant individuals, or chronic opioid users.Inclusion Criteria
I am having an open incisional hernia repair.
I am having an open surgery for a primary ventral hernia.
I am having robotic surgery for a hernia in my abdomen.
I am having surgery for an inguinal hernia.
Exclusion Criteria
I am under 18 years old.
Treatment Details
The study is testing methocarbamol as a pain treatment after hernia surgery. Participants will either receive standard opioids alone, methocarbamol alone, or both together in different groups based on the type of surgery they have.
3Treatment groups
Experimental Treatment
Group I: primary ventral hernia repair or inguinal hernia repairExperimental Treatment2 Interventions
Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias.
Primary or recurrent inguinal hernias.
Group II: open or robotic ventral hernia repair outpatientExperimental Treatment2 Interventions
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
Group III: open or robotic hernia repair inpatientExperimental Treatment2 Interventions
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
Methocarbamol is already approved in United States, Canada, European Union, Australia for the following indications:
πΊπΈ Approved in United States as Robaxin for:
- Muscle spasms
- Pain management
π¨π¦ Approved in Canada as Methocarbamol for:
- Muscle spasms
- Pain management
πͺπΊ Approved in European Union as Robaxin for:
- Muscle spasms
- Pain management
π¦πΊ Approved in Australia as Methocarbamol for:
- Muscle spasms
- Pain management
Find a clinic near you
Research locations nearbySelect from list below to view details:
Prisma HealthGreenville, SC
Loading ...
Who is running the clinical trial?
Prisma Health-UpstateLead Sponsor
References
Single dose cefotaxime plus metronidazole versus three dose cefuroxime plus metronidazole as prophylaxis against wound infection in colorectal surgery: multicentre prospective randomised study. [2019]To establish whether a single preoperative dose of cefotaxime plus metronidazole was as effective as a standard three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery.
Perioperative antibiotic prophylaxis in cardiovascular surgery: a prospective randomized comparative trial of cefazolin versus ceftriaxone. [2019]With a view of possible reduction in antibiotic dosage, several prospective randomized comparative trials performed in our institution showed that a 4-day prophylactic antimicrobial regimen with cefazolin was equally effective as a 2-day prophylaxis with cefuroxime and that the best regimen was equally as effective as a double dose of ceftriaxone prophylaxis in major cardiovascular surgery. In this prospective randomized comparative study, 1-day cefazolin prophylaxis (4 X 0.5 g intravenously) was compared with a single dose of ceftriaxone prophylaxis (2 g intravenously). Of the 900 patients enrolled in the study, 17 were subsequently excluded. Of the remaining 883 patients, 439 were in the cefazolin group and 444 were in the ceftriaxone group. The overall postoperative infection rate was 5.0% in the cefazolin group and 4.5% in the ceftriaxone group. In view of the almost identical infection rates in both groups, we considered that a single 2 g dose of ceftriaxone offers patients a reliable antimicrobial prophylaxis. The single-dose prophylaxis has the additional advantage of reducing the dosage administered and the costs of administration.
Controlled comparison of the efficacy of fourteen preparations in the relief of postoperative pain. [2019]Thirteen analgesic drugs, four of them at two dose levels, four analgesics in combination with antagonist or neuroleptic agents, and saline have been evaluated simultaneously in the relief of postoperative pain. The method of assessment was designed to favour drugs which provided freedom from pain with minimum depression of consciousness. Only levorphanol 2 mg proved significantly superior to pethidine 100 mg, which was used as the standard reference drug. Oxycodone 10 mg, pentazocine 20 mg, and the morphine 10 mg and cyclizine 50 mg combination were the most successful of the remaining drugs. None of the drug combinations was significantly better than the analgesic drug given alone.
Prevention of wound infection in elective colorectal resections by preoperative cephazolin with and without metronidazole. [2019]Fifty patients were admitted to a prospective controlled double blind trial for assessment of the effect of preoperative intramuscular cephazolin with oral metronidazole or placebo on the incidence of wound infection in patients requiring treatment by elective large intestinal resection. All patients were operated upon by one surgeon. After exclusion of two patients who died postoperatively 48 were analysed. No wound infection occurred in 22 patients receiving cephazolin with metronidazole. One (3.8%) infection developed in 26 patients receiving cephazolin with placebo. The difference did not attain statistical significance. Preoperative intramuscular cephazolin with or without metronidazole provides an effective and safe method of chemoprophylaxis for elective colorectal resection.
Anticipating and treating opioid-associated adverse effects. [2019]Opioids are frequently avoided as viable tools in the management of pain due to perceived dangerous or untoward adverse drug events. Whilst they are relatively safe options for the treatment of pain, side effects and toxicities do exist and should be anticipated by the provider. The central nervous, gastrointestinal, genito-urinary, integumentary, metabolic/endocrine, cardiovascular, pulmonary, hepatic/renal, ocular and immune systems all manifest changes associated with opioid therapy. These adverse events, ranging from nuisance to therapy-limiting, are manageable when addressed quickly and appropriately. Opioids are safe and efficacious analgesics when these effects are considered.
Effects of oxyphenbutazone (tandearil) on plasma seromucoids. II. In postoperative inflammation. [2018]The efficacy of oxyphenbutazone (OPB) in the control of postoperative inflammation was investigated, and previous findings were extended on the rate at which the inflammatory response of plasma seromucoids was significantly modified by this drug. Eighty - five surgical patients (hemorrhoidectomy, 39; vaginal hysterectomy, 23; tonsillectomy, 14; submucosal resection of nasal cavity, 9) were studied by the double-blind method. OPB was administered orally in a daily dosage of 400 mg. with a priming dose on the evening before surgery. Effective control of postsurgical inflammation was achieved in 34 of 46 treated subjects as compared with similar results in eight of 39 controls. Control of postoperative pain was pronounced when OPB was used. One patient developed an urticarial rash. Chemical studies were carried out in 65 surgical patients (39 treated with OPB; 26 controls). In the postoperative phase, mean plasma seromucoid values increased from presurgical levels by 39% in controls and by 13.9% in OPB-treated subjects. Hence, results of this clinical trial clearly demonstrate the usefulness of OPB in the control of postsurgical inflammation. Moreover, results of the chemical studies are in accordance with those previously obtained in animals.
Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. [2019]The clinical utility of most analgesic drugs is altered in the presence of patients with impaired renal or hepatic function not simply because of altered clearance of the parent drug, but also through production and accumulation of toxic or therapeutically active metabolites. Some analgesic agents may also aggravate pre-existing renal and hepatic disease. A search was performed, taking in published articles and pharmaceutical data to determine available evidence for managing acute pain effectively and safely in these two patient groups. The resulting information consisted mainly of small group pharmacokinetic studies or case reports, which included a large variation in degree of organ dysfunction. In the presence of renal impairment, those drugs which exhibit the safest pharmacological profile are alfentanil, buprenorphine, fentanyl, ketamine, paracetamol (except with compound analgesics), remifentanil and sufentanil. none of these deliver a high active metabolite load, or suffer from significantly prolonged clearance. Amitriptyline, bupivacaine, clonidine, gabapentin, hydromorphone, levobupivacaine, lignocaine, methadone, mexiletine, morphine, oxycodone and tramadol have been used in the presence of renal failure, but do require specific precautions, usually dose reduction. Aspirin, dextropropoxyphene, non-steroidal anti-inflammatory drugs and pethidine, should not be used in the presence of chronic renal failure due to the risk of significant toxicity. In the presence of hepatic impairment, most drugs are subject to significantly impaired clearance and increased oral bioavailability, but are poorly studied in the clinical setting. The agent least subject to alteration in this context is remifentanil; however the drugs' potency has other inherent dangers. Other agents must only be used with caution and close patient monitoring. Amitriptyline, carbamazepine and valproate should be avoided as the risk of fulminant hepatic failure is higher in this population, and methadone is contraindicated in the presence of severe liver disease.
Safety issues of current analgesics: an update. [2022]Pain represents a complex experience which can be approached by various medicines. Non-opioid and opioid analgesics are the most common drugs used to manage different types of pain. The increased attention nowadays to pain management entailed concomitantly more frequent adverse drug reactions (ADRs) related to analgesic use. Drug-drug interactions can be sometimes responsible for the adverse effects. However, a significant proportion of analgesic ADRs are preventable, which would avoid patient suffering. In order to draw the attention to analgesics risks and to minimize the negative consequences related to their use, the present review comprises a synthesis of the most important safety issues described in the scientific literature. It highlights the potential risks of the most frequently used analgesic medicines: non-opioid (paracetamol, metamizole, non-steroidal anti-inflammatory drugs) and opioid analgesics. Even if there is a wide experience in their use, they continue to capture attention with safety concerns and with potential risks recently revealed. Acknowledging potential safety problems represents the first step for health professionals in assuring a safe and efficient analgesic treatment with minimum risks to patients. Taking into consideration all medical and environmental factors and carefully monitoring the patients are also essential in preventing and early detecting analgesic ADRs.
Multimodal Analgesia, Current Concepts, and Acute Pain Considerations. [2022]Management of acute pain following surgery using a multimodal approach is recommended by the American Society of Anesthesiologists whenever possible. In addition to opioids, drugs with differing mechanisms of actions target pain pathways resulting in additive and/or synergistic effects. Some of these agents include alpha 2 agonists, NMDA receptor antagonists, gabapentinoids, dexamethasone, NSAIDs, acetaminophen, and duloxetine.
Use and Effectiveness of Peri-Operative Cefotetan versus Cefazolin Plus Metronidazole for Prevention of Surgical Site Infection in Abdominal Surgery Patients. [2018]Current practice guidelines for antimicrobial prophylaxis in surgery recommend a cephamycin or cefazolin plus metronidazole for various abdominal surgeries. In February 2016, cephamycin drug shortages resulted in a change in The Johns Hopkins Hospital's (JHH) recommendation for peri-operative antibiotic prophylaxis in abdominal surgeries from cefotetan to cefazolin plus metronidazole. The primary objective of this study was to quantify the percentage of abdominal surgeries adherent to JHH peri-operative antibiotic prophylaxis guidelines. A sub-group analysis investigated whether prophylaxis with cefazolin plus metronidazole was associated with a lower rate of surgical site infections (SSIs) versus cefotetan.
Oliceridine: A Novel Drug for the Management of Moderate to Severe Acute Pain - A Review of Current Evidence. [2021]Optimal pain relief requires a balance between adequate analgesia and risk of adverse effects. Opioids remain the cornerstone for managing moderate to severe pain, but are associated with opioid-induced respiratory depression (OIRD) and gastrointestinal complications. Opioids exert their analgesic effects predominantly via G-protein signaling, however, adverse effects including OIRD are mediated by the Ξ²-arrestin pathway. Oliceridine is the first of a new class of biased opioid agonists that preferentially activate G-protein signaling over Ξ²-arrestin, which would theoretically improve analgesia and reduce the risk of adverse effects. Oliceridine is approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe acute pain. The efficacy of Oliceridine was mainly established in two randomized controlled Phase III clinical trials of patients experiencing moderate to severe pain after bunionectomy (APOLLO-1) and abdominoplasty (APOLLO-2). The results of the APOLLO studies demonstrate that Oliceridine, when administered via patient-controlled analgesia (PCA) demand boluses of 0.35mg and 0.5mg, provides superior analgesia compared to placebo, and is equianalgesic to PCA morphine 1mg demand boluses, without significant difference in the incidence of respiratory complications. In a more pragmatic trial of surgical and non-surgical patients, the ATHENA observational cohort study reported rapid onset of analgesia with Oliceridine given with or without multimodal analgesia. However, these studies were designed to evaluate analgesic efficacy, and it is still uncertain if Oliceridine has a better safety profile than conventional opioids. Although several post hoc analyses of pooled data from the APOLLO and ATHENA trials reported that Oliceridine was associated with lower OIRD and gastrointestinal complications compared to morphine, prospective studies are needed to elucidate if biased agonists such as Oliceridine reduce the risk of adverse effects compared to conventional opioids.
Toxicities of opioid analgesics: respiratory depression, histamine release, hemodynamic changes, hypersensitivity, serotonin toxicity. [2022]Opioid-induced respiratory depression is potentially life-threatening and often regarded as the main hazard of opioid use. Main cause of death is cardiorespiratory arrest with hypoxia and hypercapnia. Respiratory depression is mediated by opioid μ receptors expressed on respiratory neurons in the CNS. Studies on the major sites in the brainstem mediating respiratory rate suppression, the pre-Bӧtzinger complex and parabrachial complex (including the Kӧlliker Fuse nucleus), have yielded conflicting findings and interpretations but recent investigations involving deletion of μ receptors from neurons have led to greater consensus. Some opioid analgesic drugs are histamine releasers. The range of clinical effects of released histamine include increased cardiac output due to an increase in heart rate, increased force of myocardial contraction, and a dilatatory effect on small blood vessels leading to flushing, decreased vascular resistance and hypotension. Resultant hemodynamic changes do not necessarily relate directly to the concentration of histamine in plasma due to a range of variables including functional differences between mast cells and histamine-induced anaphylactoid reactions may occur less often than commonly believed. Opioid-induced histamine release rarely if ever provokes bronchospasm and histamine released by opioids in normal doses does not lead to anaphylactoid reactions or result in IgE-mediated reactions in normal patients. Hypersensitivities to opioids, mainly some skin reactions and occasional type I hypersensitivities, chiefly anaphylaxis and urticaria, are uncommon. Hypersensitivities to morphine, codeine, heroin, methadone, meperidine, fentanyl, remifentanil, buprenorphine, tramadol, and dextromethorphan are summarized. In 2016, the FDA issued a Drug Safety Communication concerning the association of opioids with serotonin syndrome, a toxicity associated with raised intra-synaptic concentrations of serotonin in the CNS, inhibition of serotonin reuptake, and activation of 5-HT receptors. Opioids may provoke serotonin toxicity especially if administered in conjunction with other serotonergic medications. The increasing use of opioid analgesics and widespread prescribing of antidepressants and psychiatric medicines, indicates the likelihood of an increased incidence of serotonin toxicity in opioid-treated patients.
Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study. [2023]Helping Opioid Prescription Elimination (HOPE) is a project designed to provide surgeons with practical, real-world solutions to effectively manage postoperative pain and eliminate the need for opioids using HTX-011 (extended-release bupivacaine/low-dose meloxicam). In phase 3 herniorrhaphy and bunionectomy studies, HTX-011 without multimodal analgesia (MMA) was superior to bupivacaine hydrochloride in reducing pain and opioid consumption. Here, we examine the HOPE Hernia-1 study, which was designed to compare alternating ibuprofen/acetaminophen with concurrent use as part of an HTX-011-based non-opioid MMA regimen in patients undergoing herniorrhaphy and to evaluate the effectiveness of a personalized opioid prescription algorithm.
Impact of methocarbamol on opioid use after primary ventral and inguinal hernia repair. [2023]Multimodal analgesia is now a mainstay of perioperative care. Our aim is to assess the impact of adding methocarbamol on opioid use for patients undergoing primary ventral (umbilical and epigastric) hernia repair (PVHR) and inguinal hernia repair (IHR).
Impact of methocarbamol on opioid use after ventral incisional hernia repair. [2023]Alternatives to opioid analgesia are needed to reduce the risk of abuse, misuse, and diversion. Musculoskeletal pain is a significant contributor to postoperative pain after ventral hernia repair (VHR). We report the impact of methocarbamol on opioid prescribing after VHR.