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Trial record 23 of 405 for:    Recruiting, Not yet recruiting, Available Studies | "Tissue Donors"

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

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ClinicalTrials.gov Identifier: NCT03294109
Recruitment Status : Not yet recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Siamak Rahman, MD, University of California, Los Angeles

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study
liposomal bupivacain
Drug: Abdominal wall block with liposomal bupivicaine
Abdominal wall block with liposomal bupivicaine
Other Name: Exparel

No Intervention: control
no intervention



Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 90 days ]
    Visual Analog Score (VAS) for pain


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 90 days ]
    satisfaction survey

  2. Nausea and vomiting [ Time Frame: Days 1,3 and 5 ]
    Nausea and vomiting survey

  3. Return of bowel function [ Time Frame: Days 1,3 and 5 ]
    Bowl activity survey

  4. Complications; block or surgery related [ Time Frame: 90 days ]
    complications and side effects survey

  5. Opioid use dose/day [ Time Frame: 90 days ]
    Milligram Morphine Equivalent /day

  6. Return of overall health status [ Time Frame: day 10, 30, and 90 ]
    health status survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Siamak Rahman, MD (310) 267-8694 sirahman@mednet.ucla.edu
Contact: Hans A Gritsch, MD (310) 267-7727 HGritsch@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Siamak Rahman, MD University of California, Los Angeles
Principal Investigator: Hans a Gritsch, MD University of California, Los Angeles

Additional Information:
Publications:
Responsible Party: Siamak Rahman, MD, Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03294109     History of Changes
Other Study ID Numbers: 17-000598
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Siamak Rahman, MD, University of California, Los Angeles:
TQL block, TAP block, donor nephrectomy, pain, patient satisfaction

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents