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

NCT03414281 | Terminated

• 1 other identifier: cuixulei5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Nerve Block, Nephrectomy, Analgesia

Keywords

quadratus lumborum block, thoracic paravertebral block, nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• cumulative morphine consumption

  at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery

• long-term pain control

  at 48, 72 and 7 days after the surgery

• dermatomal distribution of sensory loss

  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;

Study Arms (3)

TMQLB group 1

EXPERIMENTAL

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

TMQLB group 2

EXPERIMENTAL

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

TPVB group

ACTIVE COMPARATOR

0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach.

Procedure: TPVB

Interventions

TMQLB group 1 PROCEDURE

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.

TMQLB group 1

TMQLB group 2 PROCEDURE

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.

TMQLB group 2

TPVB PROCEDURE

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.

TPVB group

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cui Xulei: lead

Study Sites (1)

Xulei CUI

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 31109368 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuguang Huang

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The attending physician

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 29, 2018
• Study Start: January 4, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)