A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine

• Sponsor: Maimonides Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03638011
• Collaborator: (none)
• Enrollment: 71
• Locations: 2
• Arms: 2
• Actual Duration (Months): 21.2
• Patients Per Site: 35.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pain control and will significantly reduce the use of post-operative IV or p.o. opiates. This is a prospective, randomized clinical trial.

Condition or Disease	Intervention/Treatment	Phase
Caesarean Section	Drug: Exparel	Phase 4

Detailed Description

The investigators will compare the analgesic efficacy and duration of an ultrasound guided bilateral TAP Block (with combined bupivacaine and liposomal bupivacaine) to Duramorph (an opiate). Neuraxial duramorph provides approximately 24 hours of pain relief (analgesia), whereas a bilateral TAP block with liposomal bupivacaine is expected to provide up to 72 hours of analgesia.

All participants will have neuraxial anesthesia (either a spinal or epidural) for their non-urgent or elective Cesarean section.

The control group (Group 1) will receive either intrathecal or epidural Duramorph (preservative-free morphine sulfate). Post-operatively, participants will have orders to receive, on an as-needed basis, IV/oral acetaminophen and/or IV/oral non-steroidal anti-inflammatory drugs (NSAIDS) for mild-moderate pain, and narcotics for severe pain; specifically- oxycodone or hydromorphone. All patients must receive acetaminophen and NSAIDS (unless contraindicated) before receiving narcotics. This multi-modal pain management regimen is our current standard of care.

The experimental group (Group 2) will also receive a spinal or epidural anesthetic. This group will not receive neuraxial Duramorph for post-operative pain. Instead, the patient will receive an ultrasound guided bilateral TAP block with a combination of bupivacaine and liposomal bupivacaine solution immediately after the Cesarean section. Additionally, all participants will receive the same post-operative analgesia orders as group 1.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a prospective, randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL delivered into the bilateral TAP blocks. TAP blocks are an excellent method for providing adequate analgesia following lower abdominal surgery. Those patients who wish to participate will be asked to sign a study consent form. Patients that decide to participate in this study will be randomized to either group 1 or group 2 (like the flip of a coin). Both groups will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control.This is a prospective, randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL delivered into the bilateral TAP blocks. TAP blocks are an excellent method for providing adequate analgesia following lower abdominal surgery. Those patients who wish to participate will be asked to sign a study consent form. Patients that decide to participate in this study will be randomized to either group 1 or group 2 (like the flip of a coin). Both groups will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel)
• Actual Study Start Date: Sep 25, 2018
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.
Active Comparator: Bilateral TAP Block These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.	Drug: Exparel; Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL; Other Names: TAP Block

Outcome Measures

Primary Outcome Measures

1. Pain Assessed by Visual Analog Scale (VAS) at 48 Hours [48 hours]

   To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).

2. Pain Assessed by Visual Analog Scale (VAS) at 72 Hours [72 hours]

   To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).

Secondary Outcome Measures

1. Number of Participants Using Narcotics [72 hours]

   Total use of narcotics during the post operative period

2. Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale [72 hours]

   Patient satisfaction with postsurgical pain management: 0_____1_____2_____3_____4_____5_____6_____7_____8_____9_____10 0=not at all satisfied 10= extremely satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Females, aged 18-45 years inclusive and ASA physical status 1-3.

• Undergoing non-urgent Cesarean section with neuraxial anesthesia/analgesia.

• Subjects must be physically and mentally able to participate in the study and complete all study assessments.

• Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a bilateral TAP infiltration.

• Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.

• Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of NSAIDs.

• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kalpana Tyagaraj	Brooklyn	New York	United States	11219
2	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Maimonides Medical Center

Investigators

• Principal Investigator: Kalpana Tyagaraj, MD, Maimonides Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 5, 2018

More Information

Publications

• Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831. Review.
• Dennis Feierman, Aden Bronstein, Miriam Flaum, Marc Dany Mohit Garg, Piyush Gupta and Kalpana Tyagaraj; A case series of 12 patient receiving bilateral Transverse Abdominis Plane blocks after cesarean section Open Journal of Anesthesiology December 2017: DOI: 10.4236/ ojanes.2017.712042
• Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.
• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15. Review.
• Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x. Review.
• Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
• Pack insert for Exparel

• Responsible Party: kalpana tyagaraj, Director of OB anesthesia, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT03638011
• Other Study ID Numbers: 2018-04-01-MMC
• First Posted: Aug 20, 2018
• Last Update Posted: Jun 7, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by kalpana tyagaraj, Director of OB anesthesia, Maimonides Medical Center: Cesarean Section; Pregnancy

Study Results

Participant Flow

Arm/Group Title	Standard of Care	Bilateral TAP Block
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.	These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Period Title: Overall Study
STARTED	38	33
COMPLETED	38	33
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard of Care	Bilateral TAP Block	Total
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.	These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL	Total of all reporting groups
Overall Participants	38	33	71
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	38 100%	33 100%	71 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.08 (4.546)	31.06 (4.062)	31.07 (4.297)
Sex: Female, Male (Count of Participants)
Female	38 100%	33 100%	71 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	38 100%	33 100%	71 100%

Outcome Measures

1. Primary Outcome

Title	Pain Assessed by Visual Analog Scale (VAS) at 48 Hours
Description	To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Bilateral TAP Block
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.	These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Measure Participants	38	33
Mean (Standard Deviation) [units on a scale]	1.97 (2.099)	1.70 (2.084)

2. Primary Outcome

Title	Pain Assessed by Visual Analog Scale (VAS) at 72 Hours
Description	To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Bilateral TAP Block
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.	These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Measure Participants	36	30
Mean (Standard Deviation) [units on a scale]	0.67 (1.531)	0.93 (1.574)

3. Secondary Outcome

Title	Number of Participants Using Narcotics
Description	Total use of narcotics during the post operative period
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Bilateral TAP Block
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.	These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Measure Participants	38	33
Number [participants]	22 57.9%	22 66.7%

4. Secondary Outcome

Title	Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale
Description	Patient satisfaction with postsurgical pain management: 0_____1_____2_____3_____4_____5_____6_____7_____8_____9_____10 0=not at all satisfied 10= extremely satisfied
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Bilateral TAP Block
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.	These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Measure Participants	38	33
Mean (Standard Deviation) [units on a scale]	9.18 (0.926)	9.00 (1.904)

Adverse Events

Time Frame	2 years
Arm/Group Title	Standard of Care		Bilateral TAP Block
Arm/Group Description	These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.		These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
All Cause Mortality
	Standard of Care		Bilateral TAP Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/33 (0%)
Serious Adverse Events
	Standard of Care		Bilateral TAP Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Bilateral TAP Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.