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Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03652116
Enrollment
78
Registered
2018-08-29
Start date
2017-04-21
Completion date
2018-08-01
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Pain

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.

Interventions

DRUGWound infiltration by Bupivacaine

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

DRUGWound infiltration by Pethidine

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative wound pain: VASfirst 24 hours postoperativelyPostoperative 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

MeasureTime frameDescription
Total dose of opioid drugs neededfirst 24 hours postoperativelyTotal dose of extra opioid drugs needed to achieve postoperative analgesia
Incidence of nausea and vomitingfirst 24 hours postoperativelyNumber of patients experiencing nausea and vomiting
Incidence of urine retentionfirst 24 hours postoperativelyNumber of patients experiencing urinary retention
Incidence of hypotensionfirst 24 hours postoperativelyNumber of patients experiencing hypotension

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026