NCT02328378

Brief Summary

The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents produces extensive analgesia and prolonged action of the injected local anesthetic solution. Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia. The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management in patients who had cesarean section under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable postoperative-pain

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

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

December 25, 2014

Last Update Submit

May 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total morphine used in the first 48 hours after surgery

    Total cumulative morphine dose in mg used in the first 48 hours after surgery

    48 hours

Secondary Outcomes (3)

  • Nausea or vomiting

    48 hours

  • Sedation score in the first 48 hours

    48 hours

  • Severity of postoperative pain via visual analogue pain scale

    48 hours

Study Arms (2)

Quadratus Lumborum block group (QL)

ACTIVE COMPARATOR

patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

Procedure: Quadratus Lumborum block

Control Group

PLACEBO COMPARATOR

patients will receive a bilateral placebo block

Procedure: Quadratus Lumborum block

Interventions

Patients will receive a bilateral Quadratus Lumborum block using 0.125% Bupivacaine in a dose of 0.2ml/kg body weight, after the end of surgery.

Control GroupQuadratus Lumborum block group (QL)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective caesarean sections
  • ASA 1 to 3
  • Written informed consent.

You may not qualify if:

  • Patient refusal
  • Local infection at the site of injection
  • Allergy to study medications
  • Sepsis
  • Anatomic abnormalities
  • Systemic anticoagulation or coagulopathy
  • Inability to comprehend or participate in pain scoring system
  • Inability to use intravenous patient controlled analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corniche Hospital

Abu Dhabi, 3788, United Arab Emirates

Location

Related Publications (1)

  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Rafa Blanco, FRCA

    Corniche Hospital

    PRINCIPAL INVESTIGATOR
  • Tarek Ansari, FFARCSI

    Corniche Hospital

    PRINCIPAL INVESTIGATOR
  • Emad Girgis, MD

    Corniche Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Anesthetist

Study Record Dates

First Submitted

December 25, 2014

First Posted

December 31, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations