Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament for Analgesia After Open Liver Surgery

NCT04668391 | Completed

• 1 other identifier: IRB-2020-350
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.

Conditions

Liver Surgery

Outcome Measures

Primary Outcomes (1)

• NRS (numeric rating scale) score for coughing pain

  Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)

  at 24 hours after surgery

Secondary Outcomes (14)

• NRS score for rest and coughing pain

  at 1, 6, 24, 48, 72 hours after surgery

• consumption of opioid converted to IV morphine equivalents

  during 24 hours after surgery

• Numbers of additional analgesics

  during 72 hours after surgery

• The incidence of postoperative hypotension

  during 72 hours after surgery

• The incidence of nausea and vomiting

  during 72 hours after surgery

Study Arms (2)

Quadratus lumborum block

EXPERIMENTAL

Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament.

Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament

Thoracic epidural analgesia

ACTIVE COMPARATOR

Thoracic epidural analgesia at the level of T7-10.

Procedure: Thoracic epidural analgesia

Interventions

Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament PROCEDURE

Bilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose.

Quadratus lumborum block

Thoracic epidural analgesia PROCEDURE

A thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h.

Thoracic epidural analgesia

Eligibility Criteria

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

You may qualify if:

• Age≥18 years
• ASA I-III
• Open liver surgery

You may not qualify if:

• Contraindication to nerve block or epidural puncture
• Chronic use of opioids or NSAIDs
• Refused to participate in the study

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (2)

• Li H, Ma D, Liu Y, Wang Y. A transverse approach for ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament. Anaesthesia. 2020 Oct;75(10):1400-1401. doi: 10.1111/anae.15058. Epub 2020 Jun 24. No abstract available.

  PMID: 32578192 BACKGROUND

• Gu B, Zhou H, Lian Y, Zhou Y, He S, Xie K, Jiang H. Ultrasound-Guided Anterior Quadratus Lumborum Block at Lateral Supra-Arcuate Ligament vs Thoracic Epidural Analgesia after Open Liver Surgery: A Randomized, Controlled, Noninferiority Trial. J Am Coll Surg. 2022 Dec 1;235(6):871-878. doi: 10.1097/XCS.0000000000000354. Epub 2022 Nov 15.

  PMID: 36102582 DERIVED

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Huifang Jiang, M.D.

  Zhejiang Caner Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 16, 2020
• Study Start: December 17, 2020
• Primary Completion: June 2, 2021
• Study Completion: July 2, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: permanent validity
• Access Criteria: Baidu Netdisk code：3i81

Locations

CN (1)