Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

December 31, 2019 updated by: Cui Xulei, Peking Union Medical College Hospital
This prospective, randomized control study aims to compare the analgesic effect, satisfaction with anesthesia and analgesia between single-injection QLB (quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 laparoscopic adrenalectomy
  • Informed consent

Exclusion Criteria:

  • a known allergy to the medications being used for anesthesia
  • coagulopathy or on anticoagulants
  • chronic opioid therapy or history of substance abuse
  • participating in another RCT
  • inability to properly describe postoperative pain to investigators (e.g., language barrier, neuropsychiatric disorder).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-injection QLB (quadratus lumborum block)
Single-injection of QLB with local anesthetic is given preoperatively
Procedure: single-injection QLB(quadratus lumborum block)

Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major muscle

Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan

Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine is given immediately after the correct position of needle tip is verified.
Placebo Comparator: Placebo control
Single-injection of QLB with NS is given preoperatively
Procedure: Placebo Control

Inject 0.4ml/kg saline between quadratus lumborum and psoas major muscle

Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan

Drug: single dose 0.4ml/kg 0.9% NS is given immediately after the correct position of the needle tip is verified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the NRS pain scores on activity 12-hours after surgery
Time Frame: 12-hours after surgery
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
12-hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Time Frame: At 2,4, 8, 12, 24 ,48,72 hours after the surgery
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
At 2,4, 8, 12, 24 ,48,72 hours after the surgery
incidence of postoperative nausea and vomiting (PONV)
Time Frame: within 24 postoperative hours
within 24 postoperative hours
ambulation time
Time Frame: within 5 days after surgery
within 5 days after surgery
time of recovery of bowel movement
Time Frame: within 5 days after surgery
defined as the time to first flatus
within 5 days after surgery
postoperative length of hospital stay
Time Frame: up to 2 weeks after surgery
up to 2 weeks after surgery
patient's satisfaction of anesthesia and analgesia
Time Frame: 48 hours after surgery
use the Chinese version of Bauer questionnaire to assess the patient satisfaction of anesthesia
48 hours after surgery
the NRS pain scores on activity after surgery
Time Frame: At 2,4, 8, 24 ,48,72 hours after the surgery
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
At 2,4, 8, 24 ,48,72 hours after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Yuguang Huang, PUMCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Actual)

August 28, 2019

Study Completion (Actual)

September 2, 2019

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cuixulei8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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