Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03652116

Collaborator

(none)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstetric Pain	Drug: Wound infiltration by Bupivacaine Drug: Wound infiltration by Pethidine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial

Actual Study Start Date :

Apr 21, 2017

Actual Primary Completion Date :

Jun 10, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine Group Patients delivered by cesarean section followed by wound infiltration by bupivacaine.	Drug: Wound infiltration by Bupivacaine Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound
Active Comparator: Pethidine Group Patients delivered by cesarean section followed by wound infiltration by pethidine.	Drug: Wound infiltration by Pethidine Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound

Arm

Intervention/Treatment

Active Comparator: Bupivacaine Group

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

Drug: Wound infiltration by Bupivacaine

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

Active Comparator: Pethidine Group

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

Drug: Wound infiltration by Pethidine

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

Outcome Measures

Primary Outcome Measures

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

Total dose of opioid drugs needed [first 24 hours postoperatively]
Total dose of extra opioid drugs needed to achieve postoperative analgesia
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
Incidence of hypotension [first 24 hours postoperatively]
Number of patients experiencing hypotension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain SHams Maternity Hospital	Cairo	Abbaseya	Egypt	002

Sponsors and Collaborators

Ain Shams University

Investigators

Study Director: Mohamed Samy, MD, M Samy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sarah Safwat, Lecturer in Obstetrics and Gynecology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03652116

Other Study ID Numbers:

PostCSLA

First Posted:

Aug 29, 2018

Last Update Posted:

Aug 31, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Labor Pain

Meperidine

Bupivacaine

Study Results

No Results Posted as of Aug 31, 2018