NCT02489851

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 may produce extensive analgesia and prolonged action of the injected local anesthetic solution. Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques. The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block 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
76

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

July 2, 2015

Last Update Submit

May 22, 2016

Conditions

Postoperative Pain

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)

  • Severity of postoperative pain via visual analogue pain scale (VAS)

    48 hours

  • Nausea or vomiting

    48 hours

  • Sedation score

    48 hours

Study Arms (2)

Quadratus Lumborum block group

ACTIVE COMPARATOR

Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

Procedure: Quadratus Lumborum block

Transversus abdominis plane block group

ACTIVE COMPARATOR

Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%

Procedure: Tranversus Abdominis plane block

Interventions

Quadratus Lumborum blockPROCEDURE

0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle

Also known as: QLB
Quadratus Lumborum block group
Tranversus Abdominis plane blockPROCEDURE

0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.

Also known as: TAP
Transversus abdominis plane block group

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, 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: 27755488DERIVED

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

  • Nanda Shetty, 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

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 3, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 24, 2016

Record last verified: 2015-12

Locations

AE(1)