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Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy

Primary Purpose

Pain Postoperative

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Transmuscular quadratus lumborum block
morphine
ropivacaine
Sponsored by
Kuala Lumpur General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Postoperative focused on measuring Transmuscular quadratus lumborum block, total abdominal hysterectomy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA I or II
  2. Patient's weight > 50kg
  3. Elective TAH

Exclusion Criteria:

  1. Body mass index (BMI) > 35 kg/m2
  2. Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA
  3. Inability to use patient controlled analgesia
  4. Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition

Sites / Locations

  • Hospital Kuala Lumpur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transmuscular quadratus lumborum (QL) block

Control

Arm Description

Bilateral QL block using 20 ml 0.375% ropivacaine in each side (to a maximum dose 3 mg/kg) plus patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative

Patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative

Outcomes

Primary Outcome Measures

Cumulative morphine consumption
in mg for 24 hours
Pain score at rest and movement
using visual analogue scale 1 to 10

Secondary Outcome Measures

Complications related to the transmuscular QL block
Complications related to transmuscular QL block: Haematoma at site of injection,infection at site of injection Complications related to PCAM:Nausea, vomiting, pruritus, sedation

Full Information

First Posted
October 23, 2015
Last Updated
June 18, 2017
Sponsor
Kuala Lumpur General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02586454
Brief Title
Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy
Official Title
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Total Abdominal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuala Lumpur General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia. Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against somatic and visceral pain as local anaesthetic tends to spread from the site of injection to thoracic paravertebral spaces where the sympathetic chain lies. The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is patients given transmuscular QL block will have lower cumulative opioid consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Postoperative
Keywords
Transmuscular quadratus lumborum block, total abdominal hysterectomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transmuscular quadratus lumborum (QL) block
Arm Type
Experimental
Arm Description
Bilateral QL block using 20 ml 0.375% ropivacaine in each side (to a maximum dose 3 mg/kg) plus patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative
Intervention Type
Procedure
Intervention Name(s)
Transmuscular quadratus lumborum block
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Primary Outcome Measure Information:
Title
Cumulative morphine consumption
Description
in mg for 24 hours
Time Frame
24 hours after total abdominal hysterectomy
Title
Pain score at rest and movement
Description
using visual analogue scale 1 to 10
Time Frame
24 hours after total abdominal hysterectomy
Secondary Outcome Measure Information:
Title
Complications related to the transmuscular QL block
Description
Complications related to transmuscular QL block: Haematoma at site of injection,infection at site of injection Complications related to PCAM:Nausea, vomiting, pruritus, sedation
Time Frame
24 hours after total abdominal hysterectomy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I or II Patient's weight > 50kg Elective TAH Exclusion Criteria: Body mass index (BMI) > 35 kg/m2 Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA Inability to use patient controlled analgesia Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amiruddin Nik Mohamed Kamil, MBBS MMed (Anaesthesiology)
Organizational Affiliation
Kuala Lumpur General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18020088
Citation
Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
Results Reference
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PubMed Identifier
23811424
Citation
Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
Results Reference
background
PubMed Identifier
21851346
Citation
Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
Results Reference
background
PubMed Identifier
24249997
Citation
Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
Results Reference
background
PubMed Identifier
25788791
Citation
Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
Results Reference
background
PubMed Identifier
23927552
Citation
Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
Results Reference
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Links:
URL
http://www.dara-esra.nl/downloads/februari13/DARA%20symposium%202013.%20US%20guided%20Quadratu%20Lumb.Block.%20J.%20Borglum.pdf
Description
Related Info
URL
http://bja.oxfordjournals.org/forum/topic/brjana_el%3b9919
Description
Related Info
URL
http://cdn.intechopen.com/pdfs/38231/InTech-Abdominal_surgery_advances_in_the_use_of_ultrasound_guided_truncal_blocks_for_perioperative_pain_management.pdf
Description
Related Info

Learn more about this trial

Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy

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