Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision

Ultrasound-guided Continous Quadratus Lumborum Block: Effect on Acute Pain and Quality of Recovery After Hepatic Surgery With Right Subcostal Incision

This prospective, randomized study, control study aims to compare the analgesic effect, opioids consumption, quality of recovery, length of hospital stay and et al. between unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Study Overview

• Status: Terminated
• Conditions: Analgesia; Hepatectomy; Nerve Block
• Intervention / Treatment: Device: Philip CX50 Ultrasound Scanner; Procedure: Continous QLB (quadratus lumborum block); Drug: Ropivacaine; Drug: Morphine given as IPCA

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Xulei CUI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• Undergo hepatectomy with right J-shape subcostal incision
• Informed consent

Exclusion Criteria:

• A known allergy to the drugs being used
• Coagulopathy, on anticoagulants
• Analgesics intake, history of substance abuse
• Participating in the investigation of another experimental agent
• Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous QLB+postoperative IPCA; Single-injection of QLB (quadratus lumborum block) is given preoperatively followed with continuous infusion+ postoperative IPCA (intravenous patient control analgesia)	Device: Philip CX50 Ultrasound Scanner; The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan; Procedure: Continous QLB (quadratus lumborum block); Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion; Other Names: Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion; Drug: Ropivacaine; 0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline given immediately after the correct position of the tip of the needle has been verified.; followed with 0.2% ropivacaine infusion at a rate of 0.125ml/kg/h given through the catheter inserted in between the quadratus lumborum muscle and psoas major muscle.; Drug: Morphine given as IPCA; Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.
Active Comparator: IPCA; Postoperative IPCA (intravenous patient control analgesia) is given alone	Drug: Morphine given as IPCA; Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative morphine consumption	at 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hospital length of stay		Up to 6 weeks
The pain scores determined by the numeric rating scale (NRS, 0-10)		At 0, 2,4, 8, 12, 24 ,48,72 hours and 7 day after the surgery
Nausea and Vomiting score		At 0, 2,4, 8, 12, 24 and 48 hours after the surgery
Pruritus score		At 0, 2,4, 8, 12, 24 and 48 hours after the surgery
Ambulation time		within the 7 days after surgery
Time of recovery of bowl movement		within the 7 days after surgery
Quality of recovery	use the self-assessment 11 item QoR scale to assess the patient's recovery quality	3 days and 7 days after surgery
Patient satisfaction with anesthesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia	48 hours after surgery

Collaborators and Investigators

• Sponsor: Cui Xulei
• Investigators: Study Chair: Yuguang Huang, MD., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): May 29, 2019
• Study Completion (Actual): May 29, 2019

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: CXL4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No