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

Ultrasound-guided Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Liver Surgery
• Intervention / Treatment: Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament; Procedure: Thoracic epidural analgesia

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadratus lumborum block; 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; 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.
Active Comparator: Thoracic epidural analgesia; Thoracic epidural analgesia at the level of T7-10.	Procedure: Thoracic epidural analgesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS score for rest and coughing pain	Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)	at 1, 6, 24, 48, 72 hours after surgery
consumption of opioid converted to IV morphine equivalents	opioids given postoperatively converted to IV morphine equivalents	during 24 hours after surgery
Numbers of additional analgesics	Additional rescue analgesics were used when pain relief was inadequate (NRS >3). The choice of rescue analgesic was oxydone 5-10mg.	during 72 hours after surgery
The incidence of postoperative hypotension	Adverse reactions related to analgesia	during 72 hours after surgery
The incidence of nausea and vomiting	Adverse reactions related to analgesia	during 72 hours after surgery
The incidence of pruritus	Adverse reactions related to analgesia	during 72 hours after surgery
The incidence of respiratory depression	Adverse reactions related to analgesia	during 72 hours after surgery
Time to ambulation in days	Postoperative ambulation time	through study completion, an average of 2-3 days
Time to eat in days	Time to start eating after surgery	through study completion, an average of 2-3 days
Time to flatus in hours	Time to flatus after surgery	through study completion, an average of 40-50 hours
Time to defecation in hours	Time to defecation after surgery	through study completion, an average of 60-70 hours
Time to urethral catheter removal in hours	Time tourethral catheter removal after surgery	through study completion, an average of 60-70 hours
Postoperative hospital stay in days	The time from operation to discharge	through study completion, an average of 7-8 days
Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication	Postoperative Clavien-Dindo complication classification	One month after surgery

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Huifang Jiang, M.D., Zhejiang Caner Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB-2020-350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Postoperative numeric rating scale (NRS) pain score at rest and during coughing at 1, 6, 24, 48 and 72 hours after surgery.
• IPD Sharing Time Frame: permanent validity
• IPD Sharing Access Criteria: Baidu Netdisk code：3i81

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No