Depo-Medrol for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Hardeep Singh
Must not be taking: Chronic oral steroids
Disqualifiers: Scoliosis, Spondylolisthesis, Diabetes, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether an injection of a steroid called Depo-medrol can help reduce hip and thigh pain after a specific type of back surgery. The goal is to see if this injection can make recovery easier for patients by reducing pain and weakness in the hip area. Depo-medrol, a corticosteroid, has been used in various medical contexts to reduce pain and inflammation, including postoperative settings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are a chronic oral steroid user, you cannot participate in the trial.
What data supports the effectiveness of the drug Depo-Medrol for postoperative pain?
Research shows that methylprednisolone acetate (Depo-Medrol) can significantly reduce postoperative pain and the need for pain medication after surgeries like lumbar discectomy and root canal treatment. It has been effective in decreasing pain intensity and the use of strong painkillers, leading to shorter hospital stays.
12345Is Depo-Medrol generally safe for use in humans?
Depo-Medrol (methylprednisolone acetate) has been associated with serious complications when injected incorrectly, such as vision loss and tissue damage in the eye area. However, when used properly, it has been shown to reduce pain after certain medical procedures.
12467How does the drug Depo-Medrol differ from other treatments for postoperative pain?
Depo-Medrol is unique because it is a slow-release corticosteroid (a type of anti-inflammatory drug) that can be injected to provide long-lasting pain relief, unlike other treatments that may require more frequent dosing. Its ability to reduce inflammation and pain over an extended period makes it different from standard pain medications that might not have the same prolonged effect.
12489Eligibility Criteria
This trial is for adults aged 18-75 with lumbar disc degeneration who are undergoing a specific back surgery (LLIF) involving the L3-4 and/or L4-5 spinal levels. Candidates must not have severe spine curvature, advanced spondylolisthesis, flatback deformity, diabetes requiring insulin, or be chronic oral steroid users. They also can't have allergies to steroids like Depo-Medrol.Inclusion Criteria
Patients from the practices of Drs. Singh, Mallozzi, Moss
Patients who agree to be a part of the study
I have degeneration in my lumbar disc.
+2 more
Exclusion Criteria
I am not fluent in English.
My spine condition is more severe than a mild slip.
I need surgery on both sides of my spine through the psoas muscle.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a Depo-Medrol injection or placebo following transpsoas lateral lumbar interbody fusion (LLIF) surgery
12 weeks
3 visits (in-person) at 2-3, 6, and 12 weeks post-surgery
Follow-up
Participants are monitored for safety and effectiveness, including assessments of thigh pain, hip flexor weakness, and numbness
2 years
Multiple visits (in-person) at 6 months, 1 year, and 2 years
Long-term Follow-up
Extended monitoring of fusion rates and patient-reported outcomes
2 years
Participant Groups
The study tests whether injecting Depo-Medrol into the psoas muscle after LLIF surgery reduces postoperative hip flexor weakness and thigh pain/numbness. It compares this treatment against Gel-Flow NT to see which is more effective in managing these symptoms.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test group (standard care + study intervention)Experimental Treatment2 Interventions
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
Group II: Control group (standard care)Placebo Group1 Intervention
1 cc gel foam powder mixed with thrombin
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UConn HealthFarmington, CT
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Who Is Running the Clinical Trial?
Hardeep SinghLead Sponsor
Society for Minimally Invasive Spine SurgeryCollaborator
References
Management of diskogenic pain using epidural and intrathecal steroids. [2019]The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.
Intraligamentary injection of slow-release methylprednisolone for the prevention of pain after endodontic treatment. [2019]The intraligamentary injection of a slow-release steroidal, the anti-inflammatory agent slow-release methylprednisolone (Depomedrol), was compared to a placebo and to an active placebo (Mepivacaine) in preventing postoperative pain after root canal treatment. The results clearly demonstrated that the tested drug significantly reduced the frequency and intensity of postoperative pain sequelae in the experimental set-up.
Benefits of epidural methylprednisolone in a unilateral lumbar discectomy: a matched controlled study. [2013]The effects of instilling methylprednisolone acetate (MP) (Depo-Medrol) onto the exposed nerve root during a unilateral lumbar laminotomy (either L4 or L5) for disc excision was studied in 43 patients (primary: 35; repeated procedure: 8). The results were compared with two similarly matched control groups without the steroid drug. All 86 patients preoperatively experienced radicular pain to the calf, and were operated on by one surgeon. Four parameters, studied during the postoperative hospital stay, were compared between the control and MP series. The MP (primary/repeat) groups' (a) stay was reduced by 37/40%, respectively; (b) need for strong narcotic drugs was decreased by 64/70%; (c) need for milder pain medication was decreased by 49/72%; and (d) need for spasm medication was reduced by 77/59%. The paired t test indicated that there is a statistical difference between the MP and control groups' results because of the use of MP, with confidence levels of 0.9927-0.9999 in the primary group, and 0.9806-0.9913 for three of the four parameters in the repeat group. Intraoperative application of epidural steroid drugs such as MP, in a unilateral low-lumbar discectomy, leads to a shorter hospital stay because of less pain and spasm.
Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]Methylprednisolone acetate (Depo-Medrol, Pfizer, New York) is a depot corticosteroid that is commonly injected periorbitally to treat various ophthalmologic conditions. Accidental intravitreal injections secondary to globe perforations have resulted in rapid retinal toxicity. To their knowledge, the authors report the first case of inadvertent intravitreal methylprednisolone acetate injection during pars plana vitrectomy.
The effect of a preoperative single-dose methylprednisolone on postoperative pain after abdominal hysterectomy: a randomized controlled trial. [2014]Methylprednisolone has been shown to have analgesic effects after orthopedic surgery. The objective of this trial was to compare the effect of 125 mg methylprednisolone with placebo on postoperative pain after abdominal hysterectomy.
Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. [2022]Two patients had uniocular visual loss after methylprednisolone acetate (Depo-Medrol) injection for control of chronic inflammatory conditions in the nose. The cause of the visual loss was embolic retinal and choroidal vascular occlusion. The emboli were presumably aggregates of microcrystals of methylprednisolone acetate.
Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. [2021]We report a case of conjunctival necrosis due to subconjunctival methylprednisolone (Depo-Medrol™) acetate injection after phacoemulsification surgery. This case report highlights a serious complication of the inadvertent use of methylprednisolone as a subconjunctival agent. To report a case of conjunctival necrosis due to subconjunctival methylprednisolone (Depo-Medrol™) acetate injection after phacoemulsification. Case report a single case presenting to a tertiary ophthalmic unit. An 82-year-old patient underwent uncomplicated phacoemulsification in the right eye. Postoperatively, she was given a subconjunctival injection of methylprednisolone. Two weeks later, she presented with a painful ulcerated lesion of the conjunctiva proximal to the injection site. The ulcerated lesion was surgically excised and she made a complete recovery. In this reported case, methylprednisolone was used in error with significant resultant morbidity. This preparation is not registered for the off label use in ophthalmology, and this case report highlights the danger of its inadvertent use as a subconjuctival agent.
Management of lumbar nerve-root pain by intrathecal and epidural injections of depot methylprednisolone acetate. [2021]Sciatica is one of the most incapacitating and difficult to treat of all benign pains. This is a report of the results of using epidural and intrathecal corticosteroids in depot form, methylprednisolone acetate (Depo-Medrol), in 108 patients who presented with a clinical diagnosis of acute lumbar disc prolapse and nerve-root pain. There was a 75% response rate in patients with less than four weeks of symptoms, whereas in patients with more than six weeks of symptoms the rate dropped to 43%. Patients with a high level of protein in their cerebrospinal fluid appeared to have a higher response rate. The treatment is most likely to be effective when the patient is male, the duration of symptoms is less than four weeks, and the patient has irritant rather than compressive neuropathy.
Methylprednisolone Does Not Reduce Persistent Pain after Cardiac Surgery. [2017]Persistent incisional pain is common after cardiac surgery and is believed to be in part related to inflammation and poorly controlled acute pain. Methylprednisolone is a corticosteroid with substantial antiinflammatory and analgesic properties and is thus likely to ameliorate persistent surgical pain. Therefore, the authors tested the primary hypothesis that patients randomized to methylprednisolone have less persistent incisional pain than those given placebo.