Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

Obstetric Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652116
• Other study ID #: PostCSLA
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 21, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 1, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

Intervention

Drug:
• Wound infiltration by Bupivacaine
Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound
• Wound infiltration by Pethidine
Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total dose of opioid drugs needed	Total dose of extra opioid drugs needed to achieve postoperative analgesia	first 24 hours postoperatively
Secondary	Incidence of nausea and vomiting	Number of patients experiencing nausea and vomiting	first 24 hours postoperatively
Secondary	Incidence of urine retention	Number of patients experiencing urinary retention	first 24 hours postoperatively
Secondary	Incidence of hypotension	Number of patients experiencing hypotension	first 24 hours postoperatively