Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision

February 7, 2016 updated by: dr mohammed elsafty, Ain Shams Maternity Hospital

Efficacy of Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision for Postoperative Cesarean Delivery Analgesia.

Local anesthetic will be injected into both angles of the rectus sheath incision in an attempt to block sensory nerves in this area that cause the sensation of pain from lscs wound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients booked for lscs
  • primisection
  • singleton pregnancy

Exclusion Criteria:

  • emergency cesarean section
  • bleeding tendency
  • hypersensitivity to local anesthetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bupivacaine group
This is the group of patients that will receive 10ml of bupivacaine 0.5% injection in both angles of the rectus sheath incision
Drug: 10ml of bupivacaine 0.5%
This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs
Placebo Comparator: saline group
This group will receive saline injections as placebo into both angles of the rectus sheath incision
Drug: Placebo
10 ml of saline will be injected as a placebo and the investigator and the patient and the data assessor are all blinded to what the patients received.
Other Names:
  • saline
Experimental: bupivacaine and saline group
This group will receive saline injection in one angle and 10ml of bupivacaine 0.5% injection in the opposite angle.
Drug: 10ml of bupivacaine 0.5%
This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs
Drug: Placebo
10 ml of saline will be injected as a placebo and the investigator and the patient and the data assessor are all blinded to what the patients received.
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain assessment during rest and ambulation by visual analogue scale
Time Frame: for 24 hours after lscs
for 24 hours after lscs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 7, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • els7680

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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