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Completed

NCT Number: NCT03652116

Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.

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Key information

Conditions

Obstetric Pain Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wound infiltration by Bupivacaine

Drug

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

Wound infiltration by Pethidine

Drug

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

Primary outcomes

  1. Postoperative wound pain: VAS

    Time frame: 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 outcomes

  1. Total dose of opioid drugs needed

    Time frame: first 24 hours postoperatively

    Total dose of extra opioid drugs needed to achieve postoperative analgesia

  2. Incidence of nausea and vomiting

    Time frame: first 24 hours postoperatively

    Number of patients experiencing nausea and vomiting

  3. Incidence of urine retention

    Time frame: first 24 hours postoperatively

    Number of patients experiencing urinary retention

  4. Incidence of hypotension

    Time frame: first 24 hours postoperatively

    Number of patients experiencing hypotension

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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