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

Liver Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04668391
• Other study ID #: IRB-2020-350
• Status: Completed
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: June 2022
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	consumption of opioid converted to IV morphine equivalents	opioids given postoperatively converted to IV morphine equivalents	during 24 hours after surgery
Secondary	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
Secondary	The incidence of postoperative hypotension	Adverse reactions related to analgesia	during 72 hours after surgery
Secondary	The incidence of nausea and vomiting	Adverse reactions related to analgesia	during 72 hours after surgery
Secondary	The incidence of pruritus	Adverse reactions related to analgesia	during 72 hours after surgery
Secondary	The incidence of respiratory depression	Adverse reactions related to analgesia	during 72 hours after surgery
Secondary	Time to ambulation in days	Postoperative ambulation time	through study completion, an average of 2-3 days
Secondary	Time to eat in days	Time to start eating after surgery	through study completion, an average of 2-3 days
Secondary	Time to flatus in hours	Time to flatus after surgery	through study completion, an average of 40-50 hours
Secondary	Time to defecation in hours	Time to defecation after surgery	through study completion, an average of 60-70 hours
Secondary	Time to urethral catheter removal in hours	Time tourethral catheter removal after surgery	through study completion, an average of 60-70 hours
Secondary	Postoperative hospital stay in days	The time from operation to discharge	through study completion, an average of 7-8 days
Secondary	Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication	Postoperative Clavien-Dindo complication classification	One month after surgery