NCT04733313

Brief Summary

to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2017

Typical duration 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

July 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 24, 2021

Last Update Submit

January 27, 2021

Conditions

Postoperative PainCesarean Section ComplicationsBlockPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Assesment of postoperative pain

    measure of the visual analog scale at rest and dynamic after surgery

    during 24 hour after surgery

Secondary Outcomes (1)

  • need of analgesic

    during 24 hour after surgery

Study Arms (2)

quadratus lumborum-2

ACTIVE COMPARATOR
Procedure: ultrasound guıded quadratus lumborum block

quadratus lumborum-3

ACTIVE COMPARATOR
Procedure: ultrasound guıded quadratus lumborum block

Interventions

ultrasound guıded quadratus lumborum blockPROCEDURE

Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.

quadratus lumborum-2quadratus lumborum-3

Eligibility Criteria

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

You may qualify if:

  • pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia
  • obtained patients informed consent

You may not qualify if:

  • inability to comprehend
  • bleeding diathesis
  • allergy to the study agents
  • localized infection
  • block failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healt Science University Bursa Training and Research Hospita

Bursa, Yildirim, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeBites and StingsPatient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPoisoningChemically-Induced DisordersWounds and InjuriesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 2, 2021

Study Start

July 15, 2017

Primary Completion

May 15, 2018

Study Completion

August 15, 2018

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)