Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

NCT03652116 | Completed Phase 2

• 1 other identifier: PostCSLA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative wound pain: VAS

  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

  first 24 hours postoperatively

Secondary Outcomes (4)

• Total dose of opioid drugs needed

  first 24 hours postoperatively

• Incidence of nausea and vomiting

  first 24 hours postoperatively

• Incidence of urine retention

  first 24 hours postoperatively

• Incidence of hypotension

  first 24 hours postoperatively

Study Arms (2)

Bupivacaine Group

ACTIVE COMPARATOR

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

Drug: Wound infiltration by Bupivacaine

Pethidine Group

ACTIVE COMPARATOR

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

Drug: Wound infiltration by Pethidine

Interventions

Wound infiltration by Bupivacaine DRUG

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

Bupivacaine Group

Wound infiltration by Pethidine DRUG

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

Pethidine Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women with known hypersensitivity to bupivacaine or pethidine.
• Women delivered vaginally.
• Women delivered under general anaesthesia.
• Women with known neurological or psychological disease.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Samy, MD

  M Samy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Obstetrics and Gynecology

Model Details: Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: April 21, 2017
• Primary Completion: June 10, 2018
• Study Completion: August 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

EG (1)