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CompletedNCT03294109Updated Jan 10, 2022Results posted

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

A Phase 4 interventional study of Abdominal wall block with liposomal bupivicaine in Pain, Postoperative, Analgesics, Opioid and Analgesics, Non-Narcotic, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • TQL block, TAP block, donor nephrectomy, pain, patient satisfaction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients undergoing laparoscopic donor nephrectomy

Exclusion criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
146 participants (actual)

Study arms

  • Experimental
    study

    liposomal bupivacain

    Drug: Abdominal wall block with liposomal bupivicaine

  • No intervention
    control

    no intervention

Interventions

  • DrugAbdominal wall block with liposomal bupivicaine

    Abdominal wall block with liposomal bupivicaine

    Also known as: Exparel

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Opioid Use Dose/Day

    Milligram Morphine Equivalent /day

    Time frame: Day 3

06

Results

Posted Nov 5, 2021

Participant flow

Participant flow — Overall Study
MilestoneStudyControl
Started4657
Underwent surgery4052
Completed4052
Not completed65
Withdrew: Withdrawal by subject65

Outcome measures

PrimaryChange 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
Reported as:
Mean · score on a scale
Change in Pain Score
score on a scaleStudyControl
Change in Pain Score4.20 ± 1.944.62 ± 1.74
SecondaryPatient 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
Reported as:
Mean · score on a scale
Patient Satisfaction With Pain Management
score on a scaleStudyControl
Patient Satisfaction With Pain Management8.6 ± 1.99.1 ± 1.2
SecondaryNausea 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
Reported as:
Count of participants · Participants
Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics
ParticipantsStudyControl
pre-op Scopolamine patch911
Rescue antiemetics in PACU68
SecondaryReturn 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
Reported as:
Mean · score on a scale
Return of Bowel Function
score on a scaleStudyControl
Return of Bowel Function1.9 ± 11.9 ± 1.1
SecondaryParticipants 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
Reported as:
Count of participants · Participants
Participants Experiencing Complications Related to Surgery or Block
ParticipantsStudyControl
Participants Experiencing Complications Related to Surgery or Block53
SecondaryOpioid Use Dose/Day

Milligram Morphine Equivalent /day

Time frame:
Day 3
Reported as:
Count of participants · Participants
Opioid Use Dose/Day
ParticipantsStudyControl
0 MME119
>0 - 5 MMe68
>5 - 10 MME38
>10-15 MME32
>15-20 MME21
>20 MME01

Adverse events

Collected over During hospitalization, up to 5 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study0/42 (0%)0/42 (0%)5/42 (11.9%)
Control0/50 (0%)0/50 (0%)3/50 (6%)
Most frequent other events
Most frequent other events
EventStudyControl
Urinary RetentionRenal and urinary disorders1/421/50
Wound infectionInjury, poisoning and procedural complications1/420/50
Contralateral flank pain and acute kidney injuryInjury, poisoning and procedural complications1/420/50
HypotensionBlood and lymphatic system disorders1/420/50
Wound seromaInjury, poisoning and procedural complications1/420/50
Pleural Effusion requiring aspirationRespiratory, thoracic and mediastinal disorders0/421/50
Incisional hematomaInjury, poisoning and procedural complications0/421/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)StudyControlTotal
<=18 years000
Between 18 and 65 years374986
>=65 years336
Sex: Female, Male
Sex: Female, Male(Participants)StudyControlTotal
Female283664
Male121628
Race (NIH/OMB)
Race (NIH/OMB)(Participants)StudyControlTotal
American Indian or Alaska Native000
Asian6612
Native Hawaiian or Other Pacific Islander000
Black or African American202
White273360
More than one race000
Unknown or Not Reported51318
Region of Enrollment
Region of Enrollment(participants)StudyControlTotal
United States405292
07

Study locations

1 site
  • Connie Frank Kidney Transplant Center
    Los Angeles, California 90095, United States
08

References and documents

Publications

  • Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28. PubMed 27891579 ↗
  • Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922. PubMed 28277325 ↗
  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299. PubMed 26225500 ↗
  • Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378. PubMed 27429253 ↗
  • Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available. PubMed 26771297 ↗
  • Gritsch HA, Osbun N, Grogan T, Fero KE, Partownavid P, Stockman J, Sadoughi N, Park E, Miller E, Blumberg J, McDonald M, Cowan N, Shah N, Rahman S. Randomized controlled trial of a quadratus lumborum block with liposomal bupivacaine for postoperative analgesia in laparoscopic donor nephrectomy. Clin Transplant. 2021 Sep;35(9):e14403. doi: 10.1111/ctr.14403. Epub 2021 Jul 14. PubMed 34184312 ↗

Study documents

  • Protocol and statistical analysis plan · May 20, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03294109
Lead sponsor
University of California, Los Angeles
Responsible party
Siamak Rahman, MD (Clinical Professor, University of California, Los Angeles) — Principal investigator
First posted
Sep 26, 2017
Start date
Jan 1, 2018
Primary completion
Jun 24, 2020
Completion
Jun 24, 2020
Results posted
Nov 5, 2021
Last update
Jan 10, 2022

Study contacts

Siamak Rahman, MD
principal investigator · University of California, Los Angeles
Hans a Gritsch, MD
principal investigator · University of California, Los Angeles

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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