Pain, Postoperative Clinical Trial
Official title:
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Verified date | December 2021 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 146 |
Est. completion date | June 24, 2020 |
Est. primary completion date | June 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Connie Frank Kidney Transplant Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
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. — View Citation
Børglum J, Gögenür I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378. Review. — View Citation
Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Børglum 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. — View Citation
Hansen CK, Dam M, Bendtsen TF, Børglum 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pain Score | Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level | 3 days post-op | |
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. | Day 1 | |
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. | Day 1 | |
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). | Day 5 | |
Secondary | Participants Experiencing Complications Related to Surgery or Block | Number of participants that experienced a related complication in each arm | Duration of inpatient stay, up to 5 days | |
Secondary | Opioid Use Dose/Day | Milligram Morphine Equivalent /day | Day 3 |
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