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

Not Applicable

Completed

• Conditions: Liver Surgery
• Interventions: Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament; Procedure: Thoracic epidural analgesia

• Registration Number: NCT04668391
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-16
• Study Start: 2020-12-17
• Primary Completion: 2021-06-02
• Study Completion: 2021-07-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus lumborum block	Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament	Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament.
Thoracic epidural analgesia	Thoracic epidural analgesia	Thoracic epidural analgesia at the level of T7-10.

Primary Outcome Measures

Name	Time	Method
NRS (numeric rating scale) score for coughing pain	at 24 hours after surgery	Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)

Secondary Outcome Measures

Name	Time	Method
The incidence of pruritus	during 72 hours after surgery	Adverse reactions related to analgesia
NRS score for rest and coughing pain	at 1, 6, 24, 48, 72 hours after surgery	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)
Time to eat in days	through study completion, an average of 2-3 days	Time to start eating after surgery
Time to defecation in hours	through study completion, an average of 60-70 hours	Time to defecation after surgery
Postoperative hospital stay in days	through study completion, an average of 7-8 days	The time from operation to discharge
Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication	One month after surgery	Postoperative Clavien-Dindo complication classification
Numbers of additional analgesics	during 72 hours after surgery	Additional rescue analgesics were used when pain relief was inadequate (NRS \>3). The choice of rescue analgesic was oxydone 5-10mg.
The incidence of postoperative hypotension	during 72 hours after surgery	Adverse reactions related to analgesia
The incidence of nausea and vomiting	during 72 hours after surgery	Adverse reactions related to analgesia
Time to urethral catheter removal in hours	through study completion, an average of 60-70 hours	Time tourethral catheter removal after surgery
The incidence of respiratory depression	during 72 hours after surgery	Adverse reactions related to analgesia
consumption of opioid converted to IV morphine equivalents	during 24 hours after surgery	opioids given postoperatively converted to IV morphine equivalents
Time to ambulation in days	through study completion, an average of 2-3 days	Postoperative ambulation time
Time to flatus in hours	through study completion, an average of 40-50 hours	Time to flatus after surgery

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China