NCT02679365

Brief Summary

In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

February 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

February 7, 2016

Last Update Submit

July 30, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative pain evaluated by VAS

    first week postoperative

Secondary Outcomes (1)

  • operative time

    intraoperative

Study Arms (2)

group a

EXPERIMENTAL

This arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath.

Procedure: lower segment cesarean section and double lock closure of rectus sheath

group b

ACTIVE COMPARATOR

This arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath.

Procedure: lower segment cesarean section and continuous non-locking closure of rectus sheath

Interventions

lower segment cesarean section and double lock closure of rectus sheathPROCEDURE
group a
lower segment cesarean section and continuous non-locking closure of rectus sheathPROCEDURE
group b

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • first cesarean section

You may not qualify if:

  • urgent cesarean section
  • previous abdominal surgery
  • previous cesarean section
  • obstetric and medical complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 10, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07