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Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

Primary Purpose

Pain Management, Nerve Block, Laparoscopic Adrenalectomy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
single-injection QLB(quadratus lumborum block)
Placebo Control
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Management focused on measuring transmuscular quadratus lumborum block, adrenalectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

single-injection QLB (quadratus lumborum block)

Placebo control

Arm Description

Single-injection of QLB with local anesthetic is given preoperatively

Single-injection of QLB with NS is given preoperatively

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the pain scores at rest determined by the numeric rating scale (NRS, 0-10)
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
incidence of postoperative nausea and vomiting (PONV)
ambulation time
time of recovery of bowel movement
defined as the time to first flatus
postoperative length of hospital stay
patient's satisfaction of anesthesia and analgesia
use the Chinese version of Bauer questionnaire to assess the patient satisfaction of anesthesia
the NRS pain scores on activity after surgery
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool

Full Information

First Posted
May 7, 2019
Last Updated
December 31, 2019
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03942237
Brief Title
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy
Official Title
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management, Nerve Block, Laparoscopic Adrenalectomy
Keywords
transmuscular quadratus lumborum block, adrenalectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-injection QLB (quadratus lumborum block)
Arm Type
Experimental
Arm Description
Single-injection of QLB with local anesthetic is given preoperatively
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Single-injection of QLB with NS is given preoperatively
Intervention Type
Procedure
Intervention Name(s)
single-injection QLB(quadratus lumborum block)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo Control
Intervention Description
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
Primary Outcome Measure Information:
Title
the NRS pain scores on activity 12-hours after surgery
Description
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
Time Frame
12-hours after surgery
Secondary Outcome Measure Information:
Title
the pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Description
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
Time Frame
At 2,4, 8, 12, 24 ,48,72 hours after the surgery
Title
incidence of postoperative nausea and vomiting (PONV)
Time Frame
within 24 postoperative hours
Title
ambulation time
Time Frame
within 5 days after surgery
Title
time of recovery of bowel movement
Description
defined as the time to first flatus
Time Frame
within 5 days after surgery
Title
postoperative length of hospital stay
Time Frame
up to 2 weeks after surgery
Title
patient's satisfaction of anesthesia and analgesia
Description
use the Chinese version of Bauer questionnaire to assess the patient satisfaction of anesthesia
Time Frame
48 hours after surgery
Title
the NRS pain scores on activity after surgery
Description
The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
Time Frame
At 2,4, 8, 24 ,48,72 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang
Organizational Affiliation
PUMCH
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34753425
Citation
Yuan Q, Lu S, Cui X, Zhang Y, Xie Y, Zhang Y, Yan W, Ji Z, Huang Y. Transmuscular quadratus lumborum block for postoperative pain and recovery after laparoscopic adrenalectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Nov 9;21(1):274. doi: 10.1186/s12871-021-01494-4.
Results Reference
derived

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Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

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