Trial Outcomes & Findings for ESP Block for Post Cesarean Analgesia (NCT NCT05664958)

NCT ID: NCT05664958

Last Updated: 2025-02-05

Results Overview

Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 150 participants
• Primary outcome timeframe: 0-48 hours after cesarean delivery
• Results posted on: 2025-02-05

Participant Flow

Participant milestones

Measure	ESP Block Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control Standard of care analgesic regimen
Overall Study STARTED	30	120
Overall Study COMPLETED	30	120
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ESP Block for Post Cesarean Analgesia

Baseline characteristics by cohort

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	120 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years n=5 Participants	33 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	120 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	16 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	92 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	120 Participants n=7 Participants	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-48 hours after cesarean delivery

Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery	12.5 mg Interval 5.0 to 40.0	25 mg Interval 3.8 to 50.0

SECONDARY outcome

Timeframe: 0-24 hours

Total dose of rescue opioids used in mg oral morphine equivalents (OME) at 24 hours after cesarean delivery. OME are approximations of the equianalgesic effects of other opioids compared to oral morphine. Thus, OMEs indicate how much of the reference drug oral morphine would be required to treat pain as effectively as the comparison opioid.

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Postoperative Opioid Consumption at 24 Hours	7.5 mg OME Interval 0.0 to 22.5	15 mg OME Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 0-48 hours

Time to first rescue opioid medication used for the treatment of breakthrough pain

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Time to First Postsurgical Opioid Rescue Medication	12.2 hours Interval 4.7 to 30.2	3.2 hours Interval 1.7 to 13.1

SECONDARY outcome

Timeframe: 0-48 hours

Area under the curve (AUC) of verbal rating scale (VRS) pain intensity scores, lower scores indicate a better outcome. The VRS consists of a scale of 0 ('no pain') to 10 ('pain as bad as it could possibly be').

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores	115 pain score unit*hours Interval 26.0 to 151.0	140 pain score unit*hours Interval 86.0 to 180.0

SECONDARY outcome

Timeframe: 0-48 hours

Population: Data about postoperative nausea and vomiting not collected on the control group.

Occurrence of nausea and vomiting 0-48 h after cesarean delivery

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control Standard of care analgesic regimen
Number of Participants With Postoperative Nausea and Vomiting	12 Participants	—

SECONDARY outcome

Timeframe: 0-48 hours

Number of participants who needed medications to treat nausea and vomiting

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Number of Participants With the Need for Rescue Antiemetics	8 Participants	48 Participants

SECONDARY outcome

Timeframe: 0-48 hours

Population: Data about pruritus not collected on the control group.

Number of participants who complained of pruritus

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control Standard of care analgesic regimen
Number of Participants With Pruritus	21 Participants	—

SECONDARY outcome

Timeframe: 0-48 hours

Number of participants who needed medications for treatment for pruritus

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Number of Participants With the Need for Rescue Antipruritics	5 Participants	30 Participants

SECONDARY outcome

Timeframe: 0-48 hours

Number of participants who did not need any opioids for break through pain

Outcome measures

Measure	ESP Block n=30 Participants Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side.	Historical Control n=120 Participants Standard of care analgesic regimen
Number of Participants Not Receiving Any Rescue Opioids Postoperatively	6 Participants	27 Participants

Adverse Events

ESP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Ashraf Haib

Duke Unversity School of Medicine

Phone: 919-668-2024

Email: ashraf.habib@duke.edu

Results disclosure agreements

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