TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

Not Applicable

Terminated

• Conditions: Nerve Block, Nephrectomy, Analgesia

• Registration Number: NCT03414281
• Lead Sponsor: Cui Xulei

Brief Summary

This trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral block (TPVB).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2019-01-04
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 17~80 years of age;
• American Society of Anesthesiologists physical status I-III;
• undergoing laparoscopic nephrectomy.

Exclusion Criteria

• have a known allergy to the anesthetics being used;
• infection at injection site
• coagulopathy or history of anticoagulants use
• chronic analgesics consumption or history of substance abuse
• inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mean VAS of the first postoperative 24 hours	within the first 24 postoperative hours	VAS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable. The VAS will be registered at 0, 2, 4, 8, 12, 24 hours after the surgery, and the primary outcome will be calculated as the mean VAS scores measured at these time point.

Secondary Outcome Measures

Name	Time	Method
nausea score	at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
pruritus score	at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale	at 3 days and 5 days after the sugery	QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well-being, and ability to carry out daily activities, where 0 indicates none of the time and 10 indicates all of the time
ambulation time	after the surgery	time to patient's first walking after the surgery
time of recovery of bowel movement	after the surgery	defined as the time to first flatus
cumulative morphine consumption	at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery	morphine consumption will be registered at 0, 2, 4, 8, 12, 24, 48, 72 hours and 7 days after the surgery and will be calculated as the sum of the values
long-term pain control	at 48, 72 and 7 days after the surgery	evaluated by VAS at 48, 72 hours and 7 days after the surgery
dermatomal distribution of sensory loss	10, 20, 30 and 40 minutes after the intervention	evaluated at 10, 20, 30 and 40 minutes after the intervention with pinprick test using Von Frey filaments
postoperative length of hospital stay	after the surgery	time to patient's discharge
patient satisfaction with anesthesia	at 48 hours after the surgery	evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery

Trial Locations

Locations (1)

Xulei CUI; 🇨🇳 Beijing, Beijing, China