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Clinical Trials/NCT05405049
NCT05405049
Completed
N/A

Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial

Ataturk University1 site in 1 country46 target enrollmentJune 16, 2022

Overview

Phase
N/A
Intervention
Bupivacain
Conditions
Analgesia
Sponsor
Ataturk University
Enrollment
46
Locations
1
Primary Endpoint
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.

Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )

Detailed Description

This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients

Registry
clinicaltrials.gov
Start Date
June 16, 2022
End Date
November 11, 2023
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aysenur Dostbil

Clinical Professor

Ataturk University

Eligibility Criteria

Inclusion Criteria

  • Pregnant women
  • 18-50 age
  • Fullterm singular pregnancy

Exclusion Criteria

  • Neuraxial anesthesia is contraindicated,
  • Allergy to the drugs to be used in the study,
  • Refused to participate in the study,
  • BMI\>35 kg/m2
  • Preeclampsia,
  • Cardiovascular disease
  • Chronic pain and neuropathic pain,
  • Given opioids in the operation due to intraoperative pain,
  • Switched to general anesthesia,
  • Excessive bleeding during the operation,

Arms & Interventions

Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI)

local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation

Intervention: Bupivacain

Group morphine ( M )

intrathecal injection of morphine with local anesthesic

Intervention: Morphine hydrochloride

Outcomes

Primary Outcomes

The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.

Time Frame: postoperative 24 hours

The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.

Secondary Outcomes

  • Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively(2,4,6,12,and 24 hours postoperatively)

Study Sites (1)

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