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Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652116
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Safwat, Ain Shams University

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

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Study Type : Interventional  (Clinical Trial)
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.
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 : April 21, 2017
Actual Primary Completion Date : June 10, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652116


Locations
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Egypt
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt, 002
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Mohamed Samy, MD M Samy

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Responsible Party: Sarah Safwat, Lecturer in Obstetrics and Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03652116    
Other Study ID Numbers: PostCSLA
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Meperidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia