Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic renal surgeries.

Study Overview

• Status: Completed
• Conditions: Pain Management; Laparoscopic Renal Surgery; Nerve Block
• Intervention / Treatment: Procedure: single-injection QLB(quadratus lumborum block); Device: Philip CX50 Ultrasound Scanner; Device: PAJUNK StimuLong; Drug: single dose ropivacaine; Drug: Morphine given as IPCA(intravenous patient controlled analgesia)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (Child, 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 laparoscopic nephrectomy
• 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-injection QLB(quadratus lumborum block); Single-injection of QLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)	Procedure: single-injection QLB(quadratus lumborum block); Inject local anesthetics in between quadratus lumborum and psoas major without continuous local infusion; Device: Philip CX50 Ultrasound Scanner; The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan; Device: PAJUNK StimuLong; Drug: single dose 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.; Drug: Morphine given as IPCA(intravenous patient controlled analgesia); bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg
Active Comparator: IPCA; postoperative IPCA is given alone	Drug: Morphine given as IPCA(intravenous patient controlled analgesia); bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative morphine consumption	within 48 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain scores determined by the numeric rating scale (NRS, 0-10)		At 0, 2,4, 8, 12, 24 ,48,72hours after the surgery
nausea and vomiting score		within 24 hours after the surgery
pruritus score		within 24hour after the surgery
ambulation time		within the 7 days after surgery
time of recovery of bowl movement		within the 5 days after surgery
quality of recovery	use the self-assessment 15 item QoR scale to assess the patient's recovery	3days and 5days after surgery
Postoperative hospital length of stay		Up to 6 weeks
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, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 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; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: cuixulei3

Plan for Individual participant data (IPD)

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