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Clinical Trials/NCT04668391
NCT04668391
Completed
Not Applicable

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

Zhejiang Cancer Hospital1 site in 1 country74 target enrollmentDecember 17, 2020
ConditionsLiver Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Surgery
Sponsor
Zhejiang Cancer Hospital
Enrollment
74
Locations
1
Primary Endpoint
NRS (numeric rating scale) score for coughing pain
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2020
End Date
July 2, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Huifang Jiang

Principal Investigator

Zhejiang Cancer Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

NRS (numeric rating scale) score for coughing pain

Time Frame: 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 Outcomes

  • The incidence of pruritus(during 72 hours after surgery)
  • NRS score for rest and coughing pain(at 1, 6, 24, 48, 72 hours after surgery)
  • Time to eat in days(through study completion, an average of 2-3 days)
  • Time to defecation in hours(through study completion, an average of 60-70 hours)
  • Postoperative hospital stay in days(through study completion, an average of 7-8 days)
  • Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication(One month 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)
  • Time to urethral catheter removal in hours(through study completion, an average of 60-70 hours)
  • The incidence of respiratory depression(during 72 hours after surgery)
  • consumption of opioid converted to IV morphine equivalents(during 24 hours after surgery)
  • Time to ambulation in days(through study completion, an average of 2-3 days)
  • Time to flatus in hours(through study completion, an average of 40-50 hours)

Study Sites (1)

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