Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

Phase 2

Completed

• Conditions: Obstetric Pain
• Interventions: Drug: Wound infiltration by Pethidine; Drug: Wound infiltration by Bupivacaine

• Registration Number: NCT03652116
• Lead Sponsor: Ain Shams University

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-21
• Primary Completion: 2018-06-10
• Status Verified: 2018-08
• Study Completion: 2018-08-01
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pethidine Group	Wound infiltration by Pethidine	Patients delivered by cesarean section followed by wound infiltration by pethidine.
Bupivacaine Group	Wound infiltration by Bupivacaine	Patients delivered by cesarean section followed by wound infiltration by bupivacaine.

Primary Outcome Measures

Name	Time	Method
Postoperative wound pain: VAS	first 24 hours postoperatively	Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups

Secondary Outcome Measures

Name	Time	Method
Total dose of opioid drugs needed	first 24 hours postoperatively	Total dose of extra opioid drugs needed to achieve postoperative analgesia
Incidence of hypotension	first 24 hours postoperatively	Number of patients experiencing hypotension
Incidence of nausea and vomiting	first 24 hours postoperatively	Number of patients experiencing nausea and vomiting
Incidence of urine retention	first 24 hours postoperatively	Number of patients experiencing urinary retention

Trial Locations

Locations (1)

Ain SHams Maternity Hospital; 🇪🇬 Cairo, Abbaseya, Egypt