Regional Anesthesia for Back Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: John O'Toole
Must not be taking: Opioids, Local anesthetics
Disqualifiers: Opioid tolerance, Indwelling pain device, Allergy to anesthetics, Chronic kidney disease, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are opioid tolerant, meaning you take more than 30mg of morphine equivalents daily.
What data supports the effectiveness of the drug Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine for back surgery?
Research shows that adding epinephrine to bupivacaine can significantly prolong the duration of anesthesia, making it more effective for surgeries. Additionally, clonidine combined with bupivacaine and epinephrine has been shown to improve pain relief during procedures, suggesting potential benefits for back surgery.
12345Is the combination of bupivacaine and epinephrine generally safe for use in humans?
The combination of bupivacaine and epinephrine, sometimes with clonidine, has been studied for various types of anesthesia and is generally considered safe, though it can cause changes in blood pressure and heart rate. Clonidine may cause sedation and has a different safety profile compared to epinephrine, which acts as a vasoconstrictor (narrows blood vessels).
46789How does regional anesthesia for back surgery differ from other treatments?
Regional anesthesia for back surgery, such as using bupivacaine, is unique because it provides targeted pain relief by blocking nerve signals in a specific area, unlike general anesthesia which affects the whole body. Bupivacaine is a long-acting local anesthetic that can be used with or without a vasoconstrictor like epinephrine to prolong its effects, making it a reliable option for surgeries requiring extended pain control.
310111213Eligibility Criteria
This trial is for adults aged 18-80 undergoing specific lumbar spinal surgeries, who can consent to participate. It's not for those with advanced kidney or liver disease, opioid tolerance, pregnancy, ongoing worker's comp cases, allergies to local anesthetics like bupivacaine or clonidine, other surgical indications besides degenerative disease, pain devices in place, or conditions affecting pain evaluation.Inclusion Criteria
I am between 18 and 80 years old.
I am scheduled for a specific spine surgery involving 1 to 3 levels of my spine.
Willing and able to give consent
Exclusion Criteria
Active pregnancy
I have advanced kidney disease or liver failure.
Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Preoperative
Patients receive either a placebo or ESPB with bupivacaine plus clonidine immediately prior to surgery
1 day
1 visit (in-person)
Treatment
Participants undergo minimally invasive lumbar spine surgery with perioperative pain management
Up to 30 days
Daily monitoring during inpatient stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, including opioid consumption and complications
90 days
Multiple follow-up assessments at 14, 56, and 90 days postoperatively
Participant Groups
The study tests if adding regional anesthesia (Bupivacaine-Epinephrine plus clonidine) reduces the need for opioids after minimally invasive lumbar spine surgery. The goal is to see if this approach can help manage post-operative pain and lower long-term opioid use.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InvestigationalExperimental Treatment1 Intervention
Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.
Group II: ControlPlacebo Group1 Intervention
Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
Loading ...
Who Is Running the Clinical Trial?
John O'TooleLead Sponsor
References
Effect of increasing amounts of epinephrine during isobaric bupivacaine spinal anesthesia in elderly patients. [2013]The effects of adding epinephrine to isobaric bupivacaine spinal anesthesia were investigated in 96 ASA class II-III patients aged 75 yr or more scheduled for lower extremity surgery. The subjects were randomly allocated into six groups. All patients received 15 mg bupivacaine plain solution in 4 ml, in the horizontal position. Patients in group 1 received bupivacaine plus 1 ml normal saline; patients in other groups received bupivacaine plus increasing dosages of epinephrine: 0.1 mg (group 2), 0.2 mg (group 3), 0.3 mg (group 4), 0.4 mg (group 5), 0.5 mg (group 6). The segmental level of sensory loss was tested using forceps. The time required for maximal spread of the sensory blockade was significantly 50% greater in group 5 than in group 1. No difference was observed, however, between mean highest levels. Addition of 0.2 mg epinephrine prolonged by a significant 25% regression time to L-2 level. Addition of 0.3 and 0.4 mg epinephrine significantly prolonged two-segment regression time by 36 and 53%, respectively, and regression to L-2 level by 29 and 44%, respectively. Addition of 0.5 mg epinephrine did not result in further prolongation of anesthesia. Motor blockade was also increased by addition of epinephrine. It is concluded that addition of 0.3 mg epinephrine may be useful to increase duration of isobaric bupivacaine spinal anesthesia.
Effects of epinephrine and clonidine on plasma concentrations of spinal bupivacaine. [2019]ASA II-III patients, scheduled for peripheral vascular surgery, were included in a study designed to assess the effect of spinal epinephrine and clonidine on plasma concentrations of spinally administered 0.5% glucose-free bupivacaine. Patients were allocated randomly to three groups to receive via a spinal catheter 22.5 mg (4.5 ml) of bupivacaine alone (Group B, 9 patients) or combined with 0.3 mg epinephrine (Group BE, 10 patients) or 0.15 mg clonidine (Group BC, 10 patients). Sensory blockade was assessed by pin-prick and motor blockade on the Bromage scale. Bupivacaine plasma concentrations were measured by gas chromatography. A trend to prolongation of local anaesthetic blockade was documented in patients receiving bupivacaine plus epinephrine or clonidine. (Time to regression of sensory blockade to L2: 170 +/- 75 min in Group B, 230 +/- 50 min in Group BE, 232 +/- 64 min in Group BC.) The maximum peak concentration (Cmax), the time to reach Cmax (Tmax) and the time-concentration curve from 0-180 min (AUC) were not different for the three groups (Cmax 228 +/- 112 ng.ml-1 in Group B, 215 +/- 103 ng.ml-1 in Group BE, 234 +/- 159 ng.ml-1 in Group BC; Tmax 41 +/- 34 min in Group B, 59 +/- 31 min in Group BE, 68 +/- 32 min in Group BC; AUC 31.0 +/- 1.7 mg.ml-1.min-1 in Group B, 27.3 +/- 1.1 mg.ml-1.min-1 in Group BE, 27.0 +/- 1.1 mg.ml-1.min-1 in Group BC). The results of this study suggest that epinephrine and clonidine do not decrease blood resorption of spinal bupivacaine.
Spinal anesthesia: bupivacaine compared with tetracaine. [2013]A solution of 0.75% bupivacaine (Marcaine) in 8.25% dextrose was compared with a similar solution of tetracaine (Pontocaine), the drug most used for spinal anesthesia in the USA. The study employed a randomized double-blind method and a standardized technique for spinal anesthesia in 435 patients. For perineal and lower extremity surgery, 7.5 mg of the local anesthetic was injected, and for intra-abdominal gynecologic surgery, 12 mg was administered. With the 7.5-mg dose, in only one of 121 patients was anesthesia unsatisfactory when bupivacaine was used; anesthesia was unsatisfactory in 19 of 114 patients when tetracaine was used. With the 12-mg dose, 12 patients given bupivacaine and 14 given tetracaine had unsatisfactory analgesia. With both doses, the motor blockade lasted significantly longer with tetracaine. Epinephrine added to the local anesthetic solution significantly increased the duration of action of both drugs. It also prolonged the duration of postoperative analgesia of tetracaine significantly more than the duration of bupivacaine. Bupivacaine 0.75% in 8.25% dextrose is a safe, reliable local anesthetic solution for spinal anesthesia.
Clonidine added to bupivacaine-epinephrine-sufentanil improves epidural analgesia during childbirth. [2019]A double-blind study was conducted to assess the efficacy and the side effects of a low dose of clonidine added to an epidural injection of bupivacaine and epinephrine, with or without sufentanil.
Hemodynamic effects of epinephrine associated to an epidural clonidine-bupivacaïne mixture during combined lumbar epidural and general anesthesia. [2013]Clonidine or epinephrine are frequently combined to epidural local anesthetics to strengthen sensory block and prolong analgesia. Both drugs impair the hemodynamic profile of central neural blockade but the effects of their combination on arterial pressure and heart rate are not known and were examined in this double-blind prospective randomised study. Forty four patients scheduled for lumbar disc surgery were allocated to two groups. Epidural anesthesia was obtained by administration of 150 micrograms clonidine in 15 ml bupivacaine 0.25% solution without (group C) or with (group C + E) 37.5 micrograms epinephrine. Systolic, mean, diastolic arterial pressure and heart rate were measured throughout the study. Combined epidural and general anesthesia induced a significant decrease in arterial pressure and heart rate in both groups. SAP and MAP decreased significantly less in the patients receiving epinephrine. Low dose epidural epinephrine decreases arterial pressure instability during combined epidural and general anesthesia.
Is clonidine an adequate alternative to epinephrine as a vasoconstrictor in patients with hypertension? [2013]To evaluate the safety and efficacy of an admixture of lidocaine with clonidine with regard to the anesthetic abilities, hemodynamic parameters, and postoperative pain control and to compare the results with those obtained with a lidocaine-epinephrine solution.
Comparison between clonidine and epinephrine admixture to lidocaine in brachial plexus block. [2022]The admixture of clonidine or epinephrine to lidocaine for brachial plexus block was studied with regard to duration of block, postoperative analgesia, and plasma concentrations of lidocaine. Thirty-three patients of ASA physical status I and II received an admixture of either clonidine (150 micrograms; n = 15) or epinephrine (200 micrograms; n = 18) to 40 mL of 1% lidocaine in a randomized, double-blind fashion. Bone surgery predominated in those patients receiving clonidine and soft-tissue surgery in those receiving epinephrine (P less than 0.05). Onset and duration of block were not different between the groups. With the admixture of clonidine, fewer patients were completely pain free for greater than 12 h (13.3%) and pain scores (visual analogue scale 0-10) were higher 6 h after the block (median 4; range 0-6) than with epinephrine (61.1%; median 2; range 0-7, respectively; P less than 0.05). In patients who had received clonidine, peak plasma concentrations of lidocaine were higher (10.29 +/- 2.96 mumol/L) and occurred earlier (23.7 +/- 9.3 min; mean +/- SD) than in those treated with epinephrine (6.9 +/- 1.71 mumol/L; 72.5 +/- 56.2 min; P less than 0.05). This indicates the absence of a local vasoconstrictor effect of clonidine and implies a reduced margin of safety with regard to local anesthetic toxicity. Although clonidine does not offer advantages compared with epinephrine, it may be a useful adjunct to local anesthetics in those patients in whom the administration of epinephrine is contraindicated.
Clinical evaluation of clonidine added to lidocaine solution for epidural anesthesia. [2022]The effects of clonidine added to lidocaine solution used for epidural anesthesia were assessed in 92 women scheduled for surgery and premedicated with diazepam 10 mg po. Patients received 18 ml 2% lidocaine with clonidine 5 micrograms.ml-1 (group C-5, n = 26), with clonidine 10 micrograms.ml-1 (group C-10, n = 20), with epinephrine 5 micrograms.ml-1 (group E, n = 26), or plain (group P, n = 20). No significant difference in the number of segments of analgesia was found at any observation period among the four groups of patients. The decreases in mean blood pressure (BP) observed 20 min after epidural injection in those given clonidine (5 +/- 8% for C-5, 10 +/- 11% for C-10, mean +/- SD) were similar to those given plain lidocaine (7 +/- 12%) but significantly less than those given epinephrine (18 +/- 12%, P less than 0.01 vs. C-5 or P). The response of BP to ephedrine given for restoring BP during anesthesia was not attenuated in patients who received epidural clonidine. Heart rate (HR) decreased significantly in patients given clonidine 10 micrograms.ml-1 (7 +/- 8%, P less than 0.01), but not in those given clonidine 5 micrograms.ml-1, whereas HR increased significantly in those given lidocaine plain or with epinephrine (10 +/- 8% and 28 +/- 14%, respectively, P less than 0.01). The incidence of sinus bradycardia was similar among the four groups of patients. Significant differences were also observed in sedation score between clonidine groups and groups P or E; sedation appeared approximately 10-20 min after epidural injection in both clonidine groups.(ABSTRACT TRUNCATED AT 250 WORDS)
Effects of adding low-dose clonidine to intrathecal hyperbaric ropivacaine: A randomized double-blind clinical trial. [2020]Clonidine added to bupivacaine prolongs the duration of anesthesia and postoperative analgesia with minimal side effects. Ropivacaine has lower lipid solubility and better safety profile as compared to bupivacaine. This study is designed to evaluate the effects of low-dose clonidine when added to hyperbaric ropivacaine.
Bupivacaine: a review of 11,080 cases. [2019]Bupivacaine (Marcaine) hydrochloride, a long-acting local anesthetic drug, was used in concentrations of 0.25, 0.5, or 0.75 percent with and without a vasoconstrictor, in amounts ranging from 25 to over 600 mg, for caudal, epidural (peridural), or peripheral nerve block for 11,080 surgical, obstetrical, diagnostic, or therapeutic procedures. Onset of anesthesia occurred in 4 to 10 minutes and maximum anesthesia in 15 to 35 minutes. Concentrations of 0.25, 0.5, and 0.75 percent consistently produced complete sensory anesthesia of the integumentary and musculoskeletal systems. With 0.25 and 0.5 percent, motor blockade ranged from minimal to complete. In intra-abdominal surgery, only 0.75 percent consistently produced profound muscle relaxation. Fifteen systemic toxic reactions occurred, but no untoward sequelae resulted from them. One inadvertent subarachnoid injection of 110 mg resulted in a total spinal block with an uneventful recovery.
Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]Bupivacaine (Marcaine), homologue of mepivacaine, chemically related to lidocaine, is used as a local anesthetic for local infiltration, peripheral nerve block, retrobulbar block, symphathetic block, and caudal and epidural anesthesia. The aim of this investigation was to determine and to compare clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor.
Hemodynamic monitoring in epidural blockade: cardiovascular effects of 20 ml 0.5% bupivacaine with and without epinephrine. [2013]Twenty patients scheduled for elective urologic surgery received epidural anesthesia with 20 ml 0.5% bupivacaine. Ten patients received an epinephrine-free solution and ten patients received epinephrine 5 micrograms.ml-1 added to the local anesthetic solution. The mean maximum level of sensory blockade was not different between the two groups (T7 and T8). After epidural administration of 20 ml of either solution, the mean arterial blood pressure decreased significantly from pre-blockade values. After administration of 0.5% bupivacaine with epinephrine, cardiac output, stroke volume and end diastolic volume increased significantly from pre-blockade control values. These changes occurred within two to four minutes after injection of the local anesthetic solution and are caused by the systemic effects of epinephrine. After 15 minutes, the ejection fraction in the plain bupivacaine group decreased significantly from pre-blockade control values and the bupivacaine with epinephrine group. The differences in hemodynamic effects of the two solutions can be explained by the vasoactive effects of epinephrine and the cardiodepressive effects of bupivacaine.
The efficacy of postoperative perineural infusion of bupivacaine and clonidine after lower extremity amputation in preventing phantom limb and stump pain. [2013]We report the efficacy of perioperative infusion of clonidine and bupivacaine for above-knee amputation in a patient with a history of phantom limb pain in the same extremity after a previous below-knee amputation. The patient underwent general anesthesia. Before transection, the sciatic nerve was infiltrated with 0.25% bupivacaine 5 mL and clonidine 50 microg. After the nerve was severed, a 20-gauge epidural catheter was inserted into the nerve sheath and externalized laterally through a separate skin incision. Before closure, 0.25% bupivacaine 10 mL and clonidine 50 microg was injected, and 0.1% bupivacaine and clonidine two microg/mL was infused at 10 mL/h for the first 96 hours postoperatively. There were no incidents of hypotension, bradycardia, or sedation during the infusion period. The mean postoperative pain score (from 0 to 10) for 96 hours was 1.2 +/- 0.7. The patient required a total of 10 mg of oxycodone postoperatively. The patient did not report either stump or phantom pain for 12 months after surgery.