NCT02586454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

October 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

October 23, 2015

Last Update Submit

June 18, 2017

Conditions

Keywords

Transmuscular quadratus lumborum block, total abdominal hysterectomy

Outcome Measures

Primary Outcomes (2)

  • Cumulative morphine consumption

    in mg for 24 hours

    24 hours after total abdominal hysterectomy

  • Pain score at rest and movement

    using visual analogue scale 1 to 10

    24 hours after total abdominal hysterectomy

Secondary Outcomes (1)

  • Complications related to the transmuscular QL block

    24 hours after total abdominal hysterectomy

Study Arms (2)

Transmuscular quadratus lumborum (QL) block

EXPERIMENTAL

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

Procedure: Transmuscular quadratus lumborum blockDrug: morphineDrug: ropivacaine

Control

ACTIVE COMPARATOR

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

Drug: morphine

Interventions

Transmuscular quadratus lumborum (QL) block
ControlTransmuscular quadratus lumborum (QL) block
Transmuscular quadratus lumborum (QL) block

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II
  • Patient's weight \> 50kg
  • Elective TAH

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Related Publications (6)

  • 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.

    PMID: 18020088BACKGROUND
  • 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.

    PMID: 23811424BACKGROUND
  • 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.

    PMID: 21851346BACKGROUND
  • 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.

    PMID: 24249997BACKGROUND
  • 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.

    PMID: 25788791BACKGROUND
  • 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.

    PMID: 23927552BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Amiruddin Nik Mohamed Kamil, MBBS MMed (Anaesthesiology)

    Kuala Lumpur General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 26, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations