NCT03112915

Brief Summary

In this study, investigators aimed to compare the Quadratus Lumborum Block and the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2018

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

February 27, 2017

Last Update Submit

September 24, 2017

Conditions

Keywords

postoperative painLaparoscopic cholecystectomyQuadratus lumborum blocktransversus abdominis plan block

Outcome Measures

Primary Outcomes (1)

  • Total cumulative morphine consumption

    Total cumulative morphine dose in mg used in the first 24 hours after surgery

    24 hour

Secondary Outcomes (2)

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

    24 hour

  • Nausea or vomiting

    24 hour

Study Arms (2)

QLB: Quadratus lumborum block

ACTIVE COMPARATOR

QLB: Quadratus lumborum block :Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.25 %

Procedure: quadratus lumborum block

TAP: transversus abdominis plan block

ACTIVE COMPARATOR

TAP: Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.25%

Procedure: Transversus abdominis plan block

Interventions

QLB: Quadratus lumborum block : 20 mL of 0.25% bupivacaine will be administered between the quadratus lumborum and the psoas major muscle bilaterally in the lateral decubitus position

Also known as: QLB
QLB: Quadratus lumborum block

TAP: transversus abdominis plan block: 20 mL of 0.25% bupivacaine will be administered between the internal oblique muscle and the transversus abdominis muscle bilaterally in the supine position

Also known as: TAP block
TAP: transversus abdominis plan block

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2-3
  • elective Laparoscopic cholecystectomy
  • years
  • 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)

Kecioren ETH

Ankara, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind randomized controlled trail
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind randomized controlled trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor

Study Record Dates

First Submitted

February 27, 2017

First Posted

April 13, 2017

Study Start

April 20, 2017

Primary Completion

August 1, 2018

Study Completion

September 12, 2018

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations