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

Primary Purpose

Pain Management, Nerve Block, Laparoscopic Adrenalectomy

Status
Terminated
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 supportive care trial for Pain Management

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 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)

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

pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery

Secondary Outcome Measures

The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
incidence of postoperative nausea and vomiting (PONV)
ambulation time
time of restart anal exhaust
Postoperative length of hospital stay
patient's satisfaction with anesthesia and analgesia
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia and analgesia
The pain scores at activity determined by the numeric rating scale (NRS, 0-10)

Full Information

First Posted
February 15, 2019
Last Updated
September 2, 2019
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03844477
Brief Title
Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
Official Title
Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
We change the study protocal
Study Start Date
February 16, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 15, 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
No

5. Study Description

Brief Summary
This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. 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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (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 without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified.
Intervention Type
Procedure
Intervention Name(s)
Placebo control
Intervention Description
Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified.
Primary Outcome Measure Information:
Title
pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery
Time Frame
At 12hours after the surgery
Secondary Outcome Measure Information:
Title
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Time Frame
At 2,4, 8, 12,24 ,48,72hours after the surgery
Title
incidence of postoperative nausea and vomiting (PONV)
Time Frame
within 24 postoperative hours
Title
ambulation time
Time Frame
within5 days after surgery
Title
time of restart anal exhaust
Time Frame
within 5 days after surgery
Title
Postoperative length of hospital stay
Time Frame
up to2 weeks after surgery
Title
patient's satisfaction with anesthesia and analgesia
Description
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia and analgesia
Time Frame
48 hours after surgery
Title
The pain scores at activity determined by the numeric rating scale (NRS, 0-10)
Time Frame
At 2,4, 8, 24 ,48,72hours 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xulei CUI, md
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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