Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03294109|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Analgesics, Opioid Analgesics, Non-Narcotic Physiological Effects of Drugs Peripheral Nervous System Agents Patient Satisfaction Return to Work Activity, Sexual||Drug: Abdominal wall block with liposomal bupivicaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||February 2020|
Drug: Abdominal wall block with liposomal bupivicaine
Abdominal wall block with liposomal bupivicaine
Other Name: Exparel
No Intervention: control
- Pain reduction [ Time Frame: 90 days ]Visual Analog Score (VAS) for pain
- Patient satisfaction [ Time Frame: 90 days ]satisfaction survey
- Nausea and vomiting [ Time Frame: Days 1,3 and 5 ]Nausea and vomiting survey
- Return of bowel function [ Time Frame: Days 1,3 and 5 ]Bowl activity survey
- Complications; block or surgery related [ Time Frame: 90 days ]complications and side effects survey
- Opioid use dose/day [ Time Frame: 90 days ]Milligram Morphine Equivalent /day
- Return of overall health status [ Time Frame: day 10, 30, and 90 ]health status survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294109
|Contact: Siamak Rahman, MD||(310) email@example.com|
|Contact: Hans A Gritsch, MD||(310) 267-7727||HGritsch@mednet.ucla.edu|
|Principal Investigator:||Siamak Rahman, MD||University of California, Los Angeles|
|Principal Investigator:||Hans a Gritsch, MD||University of California, Los Angeles|