Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision

NCT ID: NCT02285491

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cesarean Delivery Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

10ml of bupivacaine 0.5%

Intervention Type DRUG

This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs

saline group

This group will receive saline injections as placebo into both angles of the rectus sheath incision

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

bupivacaine and saline group

This group will receive saline injection in one angle and 10ml of bupivacaine 0.5% injection in the opposite angle.

Group Type EXPERIMENTAL

10ml of bupivacaine 0.5%

Intervention Type DRUG

This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs

Placebo

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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saline

Eligibility Criteria

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Inclusion Criteria

* patients booked for lscs
* primisection
* singleton pregnancy

Exclusion Criteria

* emergency cesarean section
* bleeding tendency
* hypersensitivity to local anesthetic
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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dr mohammed elsafty

Dr Mohammed Elsafty

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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els7680

Identifier Type: -

Identifier Source: org_study_id

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