Liposomal Bupivacaine for Post-Cesarean Pain
Recruiting in Palo Alto (17 mi)
Overseen byAntonio Gonzalez, MD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Yale University
Disqualifiers: Magnesium sulfate, NICU admission, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The TAP block offers analgesia by blocking the sensory nerves of the anterior abdominal wall. The procedure is performed under ultrasound guidance, after identification of the external oblique, internal oblique and transverse abdominis muscle. Medication is injected in the neurofascial plane between the internal oblique and the tranversus abdominis muscle.
Previous studies have demonstrated limited (\<24 hour) effect of the block when compared to the use of intrathecal morphine (considered to be the "gold standard" for postoperative analgesia). In a study by McMarrow et al., post-caesarian pain control combinations including TAP blocks with local anesthetic (Bupivacaine) or saline after a spinal anesthetic with or without intrathecal morphine were compared.
At 6 hours the Morphine consumption was slightly reduced in the patients that received both intrathecal morphine and TAP blocks with LA when compared to patients that received spinal saline and TAP with saline. At 24 hours the TAP block conferred no benefit in terms of opioid consumption. Similarly, the study by Lee et al. demonstrated better pain scores for the first 2 hours in patients receiving both intrathecal morphine and a TAP block with ropivacaine. At 24 hours there was no difference in the pain scores for patients that received both intrathecal morphine and TAP blocks.
On the contrary, a more recent study utilizing liposomal bupivacaine has been utilized for TAP blocks for post cesarean delivery analgesia, demonstrating opioid reductions for up to 72 hours. Liposomal bupivacaine is a novel, multivesicular formulation designed for rapid absorption, prolonged release of bupivacaine, and analgesia following a single intra-operative administration into the surgical wound or for TAP blocks.
Current anesthesia practices encourage the use of multimodal analgesia that aim at enhanced recovery after surgery (ERAS). The ERAS model aims to decrease immobility, pain and post-operative ileus. Pain and immobility may be closely related, and the latter has rarely been monitored in the post-operative setting. It is planned to use a research validated fit-bit like device (Actigraph GT3-X) to monitor patient steps (mobility).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids, you may not be eligible to participate.
What data supports the effectiveness of the drug Liposomal Bupivacaine for Post-Cesarean Pain?
Research shows that using liposomal bupivacaine in a TAP block can reduce postoperative pain and the need for opioids after surgery. Additionally, adding dexamethasone to bupivacaine in a TAP block may improve pain relief and extend the duration of pain control.
12345Is liposomal bupivacaine safe for use in humans?
Research suggests that liposomal bupivacaine is generally safe for use in humans, as studies have not reported significant adverse events when used for pain relief in various surgical procedures.
12678How is the drug liposomal bupivacaine different for post-cesarean pain?
Liposomal bupivacaine is unique because it is a long-acting form of bupivacaine that is encapsulated in tiny fat-like particles, allowing it to provide extended pain relief compared to regular bupivacaine. This can help reduce the need for opioids after a cesarean delivery.
347910Eligibility Criteria
This trial is for women aged 18-45 undergoing cesarean delivery without allergies to morphine or bupivacaine, no anxiety history, and no recent/chronic opioid use. They should be generally healthy (ASA-1 to ASA-3). Overweight individuals (BMI > 45), those needing magnesium sulfate therapy, additional surgeries beyond cesarean or whose newborns require intensive care are excluded.Inclusion Criteria
I have not used opioids recently or regularly.
You are not allergic to bupivacaine.
I am between 18 and 45 years old and will have a cesarean delivery.
+3 more
Exclusion Criteria
I need surgery beyond a C-section and possibly tying my tubes.
I need Magnesium sulfate treatment.
My BMI is over 45.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive spinal anesthesia and a TAP block with either liposomal bupivacaine, bupivacaine, or a control procedure during cesarean delivery
Immediate post-operative period
1 visit (in-person)
Post-operative Monitoring
Participants are monitored for pain management and recovery using ObsQoR-11 surveys and step counts
72 hours
Continuous monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness of a TAP block using Liposomal Bupivacaine (LB) versus standard Bupivacaine and steroids for post-cesarean pain relief. It aims to reduce opioid use by providing prolonged pain control with LB compared to short-term effects seen with traditional methods.
3Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal BupivacaineExperimental Treatment2 Interventions
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Group II: Control group (Bupivacaine)Active Control1 Intervention
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Group III: Bupivacaine + dexamethasone and methylprednisoloneActive Control1 Intervention
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale UniversityNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
References
The use of perineural dexamethasone and transverse abdominal plane block for postoperative analgesia in cesarean section operations under spinal anesthesia: an observational study. [2022]During transverses abdominal plane block (TAP) procedure to provide analgesia in cesarean section (CS) operation, the use of perineural dexamethasone as an additive agent may improve pain relief and may cause a prolonged block duration. This study aims to investigate whether perineural dexamethasone, when added to bupivacaine local anesthetic agent during a TAP block, may provide adequate pain relief without adverse events.
Effect of adding dexamethasone to bupivacaine on transversus abdominis plane block for abdominal hysterectomy: A prospective randomized controlled trial. [2022]Different adjuvants have been used to improve the quality and increase the duration of local anesthetics during various nerve block techniques. The current study was aimed to evaluate the effect of adding dexamethasone to bupivacaine on the quality and duration of transversus abdominis plane (TAP) block.
Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. [2022]Optimal pain control after major surgery contributes to a patient's recovery and satisfaction. The use of liposomal bupivacaine in subcostal transversus abdominis plane (TAP) blocks for postoperative pain control after robot assisted abdominal surgery has yet to be studied.
Timing of Transversus Abdominis Plane Block and Postoperative Pain Management. [2022]Transversus abdominis plane (TAP) blocks using liposomal bupivacaine can reduce postoperative pain and opioid consumption after surgery. The impact of timing of administration of such blocks has not been determined.
Single-Shot Liposomal Bupivacaine Reduces Postoperative Narcotic Use Following Outpatient Rotator Cuff Repair: A Prospective, Double-Blinded, Randomized Controlled Trial. [2021]Liposomal bupivacaine (LB) theoretically is longer-acting compared with conventional bupivacaine. The purpose of this study was to compare conventional bupivacaine combined with dexamethasone (control group), LB combined with conventional bupivacaine (LB group), and LB combined with dexamethasone and conventional bupivacaine (LBD group) in a perineural interscalene nerve block during ambulatory arthroscopic rotator cuff repair to determine if LB decreased postoperative narcotic consumption and pain. The effect of supplemental dexamethasone on prolonging the analgesic effect of LB was also assessed.
Effect of dexamethasone on motor brachial plexus block with bupivacaine and with bupivacaine-loaded microspheres in a sheep model. [2019]It has been suggested that dexamethasone potentiates the sensory block produced by bupivacaine when both drugs are loaded in microspheres. The aim of the study was to evaluate the effect of dexamethasone on the brachial plexus block obtained with plain bupivacaine and bupivacaine-loaded microspheres.
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]The authors provide a comprehensive summary of all randomized, controlled trials (n = 76) involving the clinical administration of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, USA) to control postoperative pain that are currently published. When infiltrated surgically and compared with unencapsulated bupivacaine or ropivacaine, only 11% of trials (4 of 36) reported a clinically relevant and statistically significant improvement in the primary outcome favoring liposomal bupivacaine. Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal bupivacaine. Results were mixed for the 16 trials comparing liposomal and unencapsulated bupivacaine, both within peripheral nerve blocks. Overall, of the trials deemed at high risk for bias, 84% (16 of 19) reported statistically significant differences for their primary outcome measure(s) compared with only 14% (4 of 28) of those with a low risk of bias. The preponderance of evidence fails to support the routine use of liposomal bupivacaine over standard local anesthetics.
Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. [2022]We compared the effect of subcostal transversus abdominis plane (TAP) block with liposomal bupivacaine to TAP block with non-liposomal bupivacaine on postoperative maximal pain scores in patients undergoing donor nephrectomy. Sixty patients were prospectively randomly assigned to receive ultrasound-guided bilateral TAPs with either 1.3% liposomal bupivacaine and normal saline or 0.25% non-liposomal bupivacaine with adrenaline. There was a significant decrease in maximal pain scores in the liposomal bupivacaine TAP group when compared with the non-liposomal bupivacaine group median (IQR [range]), 24-48 h after injection, 5 (3.0-5.2 [0-10]) vs. 6 (4.5-7.0 [1--9]) p = 0.009; 48-72 h after injection, 3 (2.0-5.0 [0-8]) vs. 5 (3.0-7.0 [0-10]) p = 0.02; and in opioid use 48-72 h after injection, mean (SD) μg equivalents of fentanyl 105 (97) vs. 182 (162) p = 0.03. Liposomal bupivacaine via subcostal TAP infiltration provided superior analgesia up to 72 h after injection when compared with non-liposomal bupivacaine.
Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial. [2022]In women undergoing cesarean delivery under spinal anesthesia with intrathecal morphine, transversus abdominis plane (TAP) block with bupivacaine hydrochloride (HCl) may not improve postsurgical analgesia. This lack of benefit could be related to the short duration of action of bupivacaine HCl. A retrospective study reported that TAP block with long-acting liposomal bupivacaine (LB) reduced opioid consumption and improved analgesia following cesarean delivery. Therefore, we performed a prospective multicenter, randomized, double-blind trial examining efficacy and safety of TAP block with LB plus bupivacaine HCl versus bupivacaine HCl alone.
Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine. [2022]To investigate efficacy and safety of liposomal bupivacaine (LB) transversus abdominis plane (TAP) block with or without intrathecal morphine (ITM) compared with ITM alone for postsurgical analgesia after cesarean delivery (CD).