Trial Outcomes & Findings for A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine (NCT NCT03638011)

NCT ID: NCT03638011

Last Updated: 2022-06-07

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 71 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2022-06-07

Participant Flow

Participant milestones

Measure	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.	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. Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Overall Study STARTED	38	33
Overall Study COMPLETED	38	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard of Care n=38 Participants 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.	Bilateral TAP Block n=33 Participants 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 n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=38 Participants	0 Participants n=33 Participants	0 Participants n=71 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=38 Participants	33 Participants n=33 Participants	71 Participants n=71 Participants
Age, Categorical >=65 years	0 Participants n=38 Participants	0 Participants n=33 Participants	0 Participants n=71 Participants
Age, Continuous	31.08 years STANDARD_DEVIATION 4.546 • n=38 Participants	31.06 years STANDARD_DEVIATION 4.062 • n=33 Participants	31.07 years STANDARD_DEVIATION 4.297 • n=71 Participants
Sex: Female, Male Female	38 Participants n=38 Participants	33 Participants n=33 Participants	71 Participants n=71 Participants
Sex: Female, Male Male	0 Participants n=38 Participants	0 Participants n=33 Participants	0 Participants n=71 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	38 Participants n=38 Participants	33 Participants n=33 Participants	71 Participants n=71 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Standard of Care n=38 Participants 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.	Bilateral TAP Block n=33 Participants 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
Pain Assessed by Visual Analog Scale (VAS) at 48 Hours	1.97 units on a scale Standard Deviation 2.099	1.70 units on a scale Standard Deviation 2.084

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Standard of Care n=36 Participants 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.	Bilateral TAP Block n=30 Participants 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
Pain Assessed by Visual Analog Scale (VAS) at 72 Hours	0.67 units on a scale Standard Deviation 1.531	0.93 units on a scale Standard Deviation 1.574

SECONDARY outcome

Timeframe: 72 hours

Total use of narcotics during the post operative period

Outcome measures

Measure	Standard of Care n=38 Participants 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.	Bilateral TAP Block n=33 Participants 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
Number of Participants Using Narcotics	22 participants	22 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care n=38 Participants 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.	Bilateral TAP Block n=33 Participants 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
Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale	9.18 units on a scale Standard Deviation 0.926	9.00 units on a scale Standard Deviation 1.904

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bilateral TAP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Dennis Feierman

Maimonides Medical Center

Phone: 718-283-6000

Email: dfeierman@maimonidesmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place