Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy
1 other identifier
interventional
75
1 country
1
Brief Summary
The enhanced recovery after surgery and laparoscopic approach have been proven beneficial in surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. This study will compare Transabdominis Plane (TAP) Block and Quadratus Lumborum (QL) Block with the common postoperative treatment with enteral and parenteral analgesics.
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 Feb 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
First Submitted
Initial submission to the registry
February 28, 2018
CompletedStudy Start
First participant enrolled
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 13, 2019
March 1, 2019
2.8 years
February 28, 2018
March 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Use of analgesics - "change" is being assessed
Amount of analgesics used postoperative
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary Outcomes (6)
Pain at the incision site - "change" is being assessed
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Deep pain and pain on coughing - "change" is being assessed
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Postoperative nausea and vomiting - "change" is being assessed
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Antiemetic administered - "change" is being assessed
1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
- +1 more secondary outcomes
Study Arms (3)
Left hemicolectomy without nerve blocks
OTHERLeft hemicolectomy, laparoscopic technique Enteral and parenteral analgesics such as paracetamol and oksykodon
Left hemicolectomy with TAP block
ACTIVE COMPARATORLeft hemicolectomy, laparoscopic technique TAP block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml
Left hemicolectomy with QL block
ACTIVE COMPARATORLeft hemicolectomy, laparoscopic technique QL block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml
Interventions
Left hemicolectomy, 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 LA
- 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: 26735154RESULTPirrera B, Alagna V, Lucchi A, Berti P, Gabbianelli C, Martorelli G, Mozzoni L, Ruggeri F, Ingardia A, Nardi G, Garulli G. Transversus abdominis plane (TAP) block versus thoracic epidural analgesia (TEA) in laparoscopic colon surgery in the ERAS program. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.
PMID: 28667547RESULTUeshima 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
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Sverre Vamnes, MD, Ph.D.
Senior Consultant
Central Study Contacts
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
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior conultant, Ph.D.
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 8, 2018
Study Start
February 28, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share