Clinical trial NCT04668391: Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament for Analgesia After Open Liver Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Surgery
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: NRS (numeric rating scale) score for coughing pain
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: NRS score for rest and coughing pain
timeFrame: at 1, 6, 24, 48, 72 hours after surgery
measure: consumption of opioid converted to IV morphine equivalents
timeFrame: during 24 hours after surgery
measure: Numbers of additional analgesics
timeFrame: during 72 hours after surgery
measure: The incidence of postoperative hypotension
timeFrame: during 72 hours after surgery
measure: The incidence of nausea and vomiting
timeFrame: during 72 hours after surgery
measure: The incidence of pruritus
timeFrame: during 72 hours after surgery
measure: The incidence of respiratory depression
timeFrame: during 72 hours after surgery
measure: Time to ambulation in days
timeFrame: through study completion, an average of 2-3 days
measure: Time to eat in days
timeFrame: through study completion, an average of 2-3 days
measure: Time to flatus in hours
timeFrame: through study completion, an average of 40-50 hours
measure: Time to defecation in hours
timeFrame: through study completion, an average of 60-70 hours
measure: Time to urethral catheter removal in hours
timeFrame: through study completion, an average of 60-70 hours
measure: Postoperative hospital stay in days
timeFrame: through study completion, an average of 7-8 days
measure: Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Caner Hospital
name: Huifang Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.