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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03294109
Enrollment
146
Registered
2017-09-26
Start date
2018-01-01
Completion date
2020-06-24
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Sexual, Analgesics, Non-Narcotic, Analgesics, Opioid, Pain, Postoperative, Patient Satisfaction, Peripheral Nervous System Agents, Physiological Effects of Drugs, Return to Work

Keywords

TQL block, TAP block, donor nephrectomy, pain, patient satisfaction

Brief summary

A blinded randomized control trial in living kidney donors. The study group will receive a liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general anesthesia. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes.

Detailed description

This is a blinded (patients are blinded and all the staff and the nurses who collect data are also blinded) randomized controlled trial in living kidney donors who have been approved by a multidisciplinary (nephrology, urology, psychiatry, and social work) team to proceed with donor nephrectomy. Patients will be approached to participate in the study only after they have agreed to kidney donation and have been informed of all of the associated risks. Participants are informed that they can withdraw from kidney donation at any time until they are in the operating room. Patients meeting these criteria, who also consent to participate in the study, will be randomized (standard of care pain medication vs TQL block). The ratio of male to female patients in each arm will be equal because of the known increased risks for post-operative nausea/vomiting (PONV) in females. The study group will receive a liposomal bupivacaine TQL block after the induction of general anesthesia and liposomal bupivacaine transverse abdominis plane (TAP) block after closure of the midline fascia. All patients including the control group will have infiltration of the skin edges with bupivacaine. Control patients will have a TAP block with 5 cc of bupivacaine on both sides. A placebo 22g needle will be placed at the same site as the TQL block without injection. Intra-operative narcotics will be administered by the anesthesia team based on standard criteria. All participants will receive intravenous ketorolac and acetaminophen at the end of the procedure. Intravenous ketorolac will be continued for 24 hours while hospitalized. Post-operative pain management with intermittent parenteral and enteral narcotics as needed will be the same in both groups. Liposomal bupivacaine block administration: After induction of general anesthesia, surgical team will turn the patient to the lateral position (final position for surgery). After prep with and drape, investigators will place ultrasound probe in mid- posterior axillary line, just above iliac crest. The investigators will identify abdominal wall muscles including external oblique, internal oblique, transverse abdominis, and quadratus lumborum as well as thoracolumbar fascia with the help of ultrasound. Then, investigators will insert a 22g nerve block needle and advanced it under direct guidance of ultrasound until it is below the fascial covering of the quadratus lumborum muscle layer or its fascia which forms a continuous fascia compartment with thoracolumbar fascia. After aspiration to rule out intravascular location of the needle, investigators will be inject 20 mL of liposomal bupivacaine mixed with 10ml of normal saline under ultrasound guidance, to monitor spread of the injected fluid . The investigators will aspirate repeatedly every 5cc of local anesthetic. The investigators will remove the needle upon completion of the injection. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in EHR. Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes Complications will be documented by anesthesia pain service that will follow these patients while admitted. Outpatient use of narcotics, pain assessment, bowel function, sexual function complications from the block or the donor surgery, and attitudes toward kidney donation will be evaluated with validated survey instruments. Please see the timeline for the collection of the data prior to and after kidney donation. The survey data will be collected using secure links to a REDCap server 3, 5, 10, 30, and 90 days after surgery.

Interventions

DRUGAbdominal wall block with liposomal bupivicaine

Abdominal wall block with liposomal bupivicaine

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing laparoscopic donor nephrectomy

Exclusion criteria

* Pregnancy * Systemic or local infection at the potential block site. * Allergy or hypersensitivity to the local anesthetic, * Possible variations in surgical approach to donor nephrectomy other than what is defined in this protocol. * Scarring or anatomic abnormality over the proposed injection site

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Score3 days post-opVisual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level

Secondary

MeasureTime frameDescription
Patient Satisfaction With Pain ManagementDay 1The 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.
Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue AntiemeticsDay 1Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.
Return of Bowel FunctionDay 5Bowl 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).
Participants Experiencing Complications Related to Surgery or BlockDuration of inpatient stay, up to 5 daysNumber of participants that experienced a related complication in each arm
Opioid Use Dose/DayDay 3Milligram Morphine Equivalent /day

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Study
ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine
40
Control
ERAS Plus laparoscopic TAP block
52
Total92

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject65

Baseline characteristics

CharacteristicTotalStudyControl
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants3 Participants3 Participants
Age, Categorical
Between 18 and 65 years
86 Participants37 Participants49 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants6 Participants6 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
18 Participants5 Participants13 Participants
Race (NIH/OMB)
White
60 Participants27 Participants33 Participants
Region of Enrollment
United States
92 participants40 participants52 participants
Sex: Female, Male
Female
64 Participants28 Participants36 Participants
Sex: Female, Male
Male
28 Participants12 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 50
other
Total, other adverse events
5 / 423 / 50
serious
Total, serious adverse events
0 / 420 / 50

Outcome results

Primary

Change in Pain Score

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

Time frame: 3 days post-op

Population: Participants who completed pain VAS survey on day 3

ArmMeasureValue (MEAN)Dispersion
StudyChange in Pain Score4.20 score on a scaleStandard Deviation 1.94
ControlChange in Pain Score4.62 score on a scaleStandard Deviation 1.74
Secondary

Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics

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

Time frame: Day 1

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
StudyNausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemeticspre-op Scopolamine patch9 Participants
StudyNausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue AntiemeticsRescue antiemetics in PACU6 Participants
ControlNausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemeticspre-op Scopolamine patch11 Participants
ControlNausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue AntiemeticsRescue antiemetics in PACU8 Participants
Secondary

Opioid Use Dose/Day

Milligram Morphine Equivalent /day

Time frame: Day 3

Population: Patients whom responded to survey on Day 3

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
StudyOpioid Use Dose/Day>10-15 MME3 Participants
StudyOpioid Use Dose/Day>0 - 5 MMe6 Participants
StudyOpioid Use Dose/Day>15-20 MME2 Participants
StudyOpioid Use Dose/Day>5 - 10 MME3 Participants
StudyOpioid Use Dose/Day>20 MME0 Participants
StudyOpioid Use Dose/Day0 MME11 Participants
ControlOpioid Use Dose/Day>20 MME1 Participants
ControlOpioid Use Dose/Day0 MME9 Participants
ControlOpioid Use Dose/Day>5 - 10 MME8 Participants
ControlOpioid Use Dose/Day>10-15 MME2 Participants
ControlOpioid Use Dose/Day>15-20 MME1 Participants
ControlOpioid Use Dose/Day>0 - 5 MMe8 Participants
Secondary

Participants Experiencing Complications Related to Surgery or Block

Number of participants that experienced a related complication in each arm

Time frame: Duration of inpatient stay, up to 5 days

Population: All enrolled patients receiving surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
StudyParticipants Experiencing Complications Related to Surgery or Block5 Participants
ControlParticipants Experiencing Complications Related to Surgery or Block3 Participants
Secondary

Patient Satisfaction With Pain Management

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.

Time frame: Day 1

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

ArmMeasureValue (MEAN)Dispersion
StudyPatient Satisfaction With Pain Management8.6 score on a scaleStandard Deviation 1.9
ControlPatient Satisfaction With Pain Management9.1 score on a scaleStandard Deviation 1.2
Secondary

Return of Bowel Function

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).

Time frame: Day 5

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

ArmMeasureValue (MEAN)Dispersion
StudyReturn of Bowel Function1.9 score on a scaleStandard Deviation 1
ControlReturn of Bowel Function1.9 score on a scaleStandard Deviation 1.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026