Trial Outcomes & Findings for Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy (NCT NCT03294109)

NCT ID: NCT03294109

Last Updated: 2022-01-10

Results Overview

Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 146 participants
• Primary outcome timeframe: 3 days post-op
• Results posted on: 2022-01-10

Participant Flow

Prior to randomization, 146 patients signed consent. Of those 146, 137 completed the intake questionnaire, a requirement for the study. Of those 137, 103 were scheduled for surgery.

Participant milestones

Measure	Study ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:	Control ERAS Plus laparoscopic TAP block
Overall Study STARTED	46	57
Overall Study Underwent Surgery	40	52
Overall Study COMPLETED	40	52
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Study ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine:	Control ERAS Plus laparoscopic TAP block
Overall Study Withdrawal by Subject	6	5

Baseline Characteristics

Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy

Baseline characteristics by cohort

Measure	Study n=40 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=52 Participants ERAS Plus laparoscopic TAP block	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=93 Participants	49 Participants n=4 Participants	86 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	36 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	16 Participants n=4 Participants	28 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	27 Participants n=93 Participants	33 Participants n=4 Participants	60 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	13 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment United States	40 participants n=93 Participants	52 participants n=4 Participants	92 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 days post-op

Population: Participants who completed pain VAS survey on day 3

Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level

Outcome measures

Measure	Study n=25 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=36 Participants ERAS Plus laparoscopic TAP block
Change in Pain Score	4.20 score on a scale Standard Deviation 1.94	4.62 score on a scale Standard Deviation 1.74

SECONDARY outcome

Timeframe: Day 1

Population: Patients who completed APS-POQ-R survey question "Satisfaction with Pain Treatments" on Day 1.

The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable "Satisfaction with Pain Treatments." This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.

Outcome measures

Measure	Study n=39 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=46 Participants ERAS Plus laparoscopic TAP block
Patient Satisfaction With Pain Management	8.6 score on a scale Standard Deviation 1.9	9.1 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day 1

Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.

Outcome measures

Measure	Study n=40 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=52 Participants ERAS Plus laparoscopic TAP block
Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics pre-op Scopolamine patch	9 Participants	11 Participants
Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics Rescue antiemetics in PACU	6 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 5

Population: Participants who completed the bowel activity survey on Day 5

Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).

Outcome measures

Measure	Study n=31 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=38 Participants ERAS Plus laparoscopic TAP block
Return of Bowel Function	1.9 score on a scale Standard Deviation 1	1.9 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Duration of inpatient stay, up to 5 days

Population: All enrolled patients receiving surgery

Number of participants that experienced a related complication in each arm

Outcome measures

Measure	Study n=42 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=50 Participants ERAS Plus laparoscopic TAP block
Participants Experiencing Complications Related to Surgery or Block	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 3

Population: Patients whom responded to survey on Day 3

Milligram Morphine Equivalent /day

Outcome measures

Measure	Study n=25 Participants ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=29 Participants ERAS Plus laparoscopic TAP block
Opioid Use Dose/Day 0 MME	11 Participants	9 Participants
Opioid Use Dose/Day >0 - 5 MMe	6 Participants	8 Participants
Opioid Use Dose/Day >5 - 10 MME	3 Participants	8 Participants
Opioid Use Dose/Day >10-15 MME	3 Participants	2 Participants
Opioid Use Dose/Day >15-20 MME	2 Participants	1 Participants
Opioid Use Dose/Day >20 MME	0 Participants	1 Participants

Adverse Events

Study

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study n=42 participants at risk ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine	Control n=50 participants at risk ERAS Plus laparoscopic TAP block
Renal and urinary disorders Urinary Retention	2.4% 1/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	2.0% 1/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.
Respiratory, thoracic and mediastinal disorders Pleural Effusion requiring aspiration	0.00% 0/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	2.0% 1/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.
Injury, poisoning and procedural complications Incisional hematoma	0.00% 0/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	2.0% 1/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.
Injury, poisoning and procedural complications Wound infection	2.4% 1/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	0.00% 0/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.
Injury, poisoning and procedural complications Contralateral flank pain and acute kidney injury	2.4% 1/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	0.00% 0/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.
Blood and lymphatic system disorders Hypotension	2.4% 1/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	0.00% 0/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.
Injury, poisoning and procedural complications Wound seroma	2.4% 1/42 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.	0.00% 0/50 • During hospitalization, up to 5 days Complications from surgery were collected as adverse events.

Additional Information

Siamak Rahman, MD

university of Californiia

Phone: 310 2678839

Email: sirahman@mednet.ucla.edu

Results disclosure agreements

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