Back to resultsTransmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy (TQL)
Primary Purpose
Cholecystitis, Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
saline
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring Laparoscopic, Cholecystectomy, Postoperative, Pain, Quadratus lumborum, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- scheduled for elective laparoscopic cholecystectomy
- received oral and written information about the trial
- American Society of Anaethesiologists (ASA) classification 1-3
- NRS score > 3 upon arrival at the PACU area
Exclusion Criteria:
- Cannot cooperate
- Does not speak or understand Danish
- Allergy towards drugs used in the trial
- Large daily consumption of opioids
- Known alcohol og medicin abuse
- Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
- Pregnancy
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Placebo TQL block
Active TQL block
Arm Description
30 ml single shot TQL block with saline 0,9%
30 ml single shot TQL block with ropivacaine 0,75%
Outcomes
Primary Outcome Measures
Pain score in sitting position
Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
Secondary Outcome Measures
Pain score at rest
NRS score after administration of TQL block at said time points
Pain score at sitting position
NRS score after administration of TQL block at said time points
Total opioid consumption in PACU area
During stay in PACU area
Opioid side effects (nausea, vomiting)
During stay in PACU area
Length of stay in PACU area
Total time in PACU area
Full Information
NCT ID
NCT02225418
First Posted
January 28, 2014
Last Updated
July 20, 2015
Sponsor
Jens Borglum Neimann
Collaborators
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02225418
Brief Title
Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy
Acronym
TQL
Official Title
Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Change of jobs
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Borglum Neimann
Collaborators
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.
The trial will compare active TQL block versus placebo TQL block after said operation.
The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Pain
Keywords
Laparoscopic, Cholecystectomy, Postoperative, Pain, Quadratus lumborum, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo TQL block
Arm Type
Sham Comparator
Arm Description
30 ml single shot TQL block with saline 0,9%
Arm Title
Active TQL block
Arm Type
Active Comparator
Arm Description
30 ml single shot TQL block with ropivacaine 0,75%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
naropin
Intervention Type
Drug
Intervention Name(s)
saline
Primary Outcome Measure Information:
Title
Pain score in sitting position
Description
Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Pain score at rest
Description
NRS score after administration of TQL block at said time points
Time Frame
15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
Title
Pain score at sitting position
Description
NRS score after administration of TQL block at said time points
Time Frame
15 min 30 min 2 hour 3 hour 4 hour 5 hour
Title
Total opioid consumption in PACU area
Description
During stay in PACU area
Time Frame
On average 3 hours
Title
Opioid side effects (nausea, vomiting)
Description
During stay in PACU area
Time Frame
On average 3 hours
Title
Length of stay in PACU area
Description
Total time in PACU area
Time Frame
On average 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for elective laparoscopic cholecystectomy
received oral and written information about the trial
American Society of Anaethesiologists (ASA) classification 1-3
NRS score > 3 upon arrival at the PACU area
Exclusion Criteria:
Cannot cooperate
Does not speak or understand Danish
Allergy towards drugs used in the trial
Large daily consumption of opioids
Known alcohol og medicin abuse
Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Børglum, MD, PhD
Organizational Affiliation
Copenhagen University Hospital Bispebjerg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400 NV
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy
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