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

Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

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).

Study Overview

• Status: Terminated
• Conditions: Nerve Block, Nephrectomy, Analgesia
• Intervention / Treatment: Procedure: TMQLB group 1; Procedure: TMQLB group 2; Procedure: TPVB

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Xulei CUI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMQLB group 1; 0.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.	Procedure: TMQLB group 1; The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane. Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Experimental: TMQLB group 2; 0.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.	Procedure: TMQLB group 2; The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane. Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Active Comparator: TPVB group; 0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach.	Procedure: TPVB; The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10. Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean VAS of the first postoperative 24 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.	within the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale	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	at 3 days and 5 days after the sugery
cumulative morphine consumption	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	at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery
long-term pain control	evaluated by VAS at 48, 72 hours and 7 days after the surgery	at 48, 72 and 7 days after the surgery
dermatomal distribution of sensory loss	evaluated at 10, 20, 30 and 40 minutes after the intervention with pinprick test using Von Frey filaments	10, 20, 30 and 40 minutes after the intervention
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;
ambulation time	time to patient's first walking after the surgery	after the surgery
time of recovery of bowel movement	defined as the time to first flatus	after the surgery
postoperative length of hospital stay	time to patient's discharge	after the surgery
patient satisfaction with anesthesia	evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery	at 48 hours after the surgery

Collaborators and Investigators

• Sponsor: Cui Xulei

Publications and helpful links

General Publications

• Yuan Q, Cui X, Fei Y, Xu Z, Huang Y. Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial. Trials. 2019 May 20;20(1):276. doi: 10.1186/s13063-019-3359-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: quadratus lumborum block, thoracic paravertebral block, nephrectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: cuixulei5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No