Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

NCT ID: NCT03652116

Last Updated: 2018-08-31

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

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2018-08-01

Brief Summary

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The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.

Detailed Description

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Conditions

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Obstetric Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupivacaine Group

Patients delivered by cesarean section followed by wound infiltration by bupivacaine.

Group Type ACTIVE_COMPARATOR

Wound infiltration by Bupivacaine

Intervention Type DRUG

Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound

Pethidine Group

Patients delivered by cesarean section followed by wound infiltration by pethidine.

Group Type ACTIVE_COMPARATOR

Wound infiltration by Pethidine

Intervention Type DRUG

Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound

Interventions

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Wound infiltration by Bupivacaine

Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound

Intervention Type DRUG

Wound infiltration by Pethidine

Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mode of delivery: Cesarean section.
* Gestational age: 37-40 weeks.
* Type of anaesthesia: Spinal anaesthesia.
* No past history of any medical disorder or other medical complications during pregnancy.

Exclusion Criteria

* Women with known hypersensitivity to bupivacaine or pethidine.
* Women delivered vaginally.
* Women delivered under general anaesthesia.
* Women with known neurological or psychological disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Safwat

Lecturer in Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Samy, MD

Role: STUDY_DIRECTOR

M Samy

Locations

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Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PostCSLA

Identifier Type: -

Identifier Source: org_study_id