The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy
1 other identifier
interventional
75
1 country
1
Brief Summary
The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2018
CompletedFirst Submitted
Initial submission to the registry
January 22, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2020
CompletedFebruary 20, 2020
February 1, 2020
1.2 years
January 22, 2018
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Use of analgesics -"change" is being assessed
Amount of analgesics used postoperative
1 week (0-4hrs) (4-24hrs) (24-48hrs)
Secondary Outcomes (4)
Pain at the incision site - "change" is being assessed
48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Deep pain and pain on coughing - "change" is being assessed
48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Postoperative nausea and vomiting - "change" is being assessed
48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Study Arms (3)
Cholecystectomy without nerve blocks
OTHERCholecystectomy, enteral and parenteral analgesics
Cholecystectomy with placebo nerve block
PLACEBO COMPARATORCholecystectomy, NaCl as a placebo Quadratus lumborum block
Cholecystectomy with naropin nerve block
ACTIVE COMPARATORCholecystectomy, Quadratus lumborum block with naropin
Interventions
Laparoscopic technique
Eligibility Criteria
You may qualify if:
- Age 18-80 Years
- BMI 20-35
- ASA physical status I-II
You may not qualify if:
- Allergy to local anaesthetics
- Chronic pain requiring opioid analgesics
- Patients with atrioventricular block II
- Patients treated with class III antiarrhythmics
- Patients with severe renal and/or hepatic disease
- A coagulation disorder
- An infection at the LA injection place
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ostfold Hospital Trust, Moss
Grålum, Østfold fylke, 1714, Norway
Related Publications (6)
Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
PMID: 27429253RESULTBlanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PMID: 27755488RESULTEl-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
PMID: 19376789RESULTMurouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
PMID: 26735154RESULTPetersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.
PMID: 22763903RESULTUeshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PMID: 28154824RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Information connecting the patients to the data are kept locked and will be destroyed after the end of the investigation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior consultant, MD, Ph.D.
Study Record Dates
First Submitted
January 22, 2018
First Posted
February 19, 2018
Study Start
January 20, 2018
Primary Completion
March 31, 2019
Study Completion
February 18, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share