Compared With Different Method for Postcesarean Section Analgesia

June 2, 2022 updated by: Aysenur Dostbil, Ataturk University

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

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 )

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Yakuti̇ye
      • Erzurum, Yakuti̇ye, Turkey, 25100
        • Atatürk üniversty medicine school
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women
  • 18-50 age
  • ASA II
  • 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
  • ASA≥3
  • Diabetes
  • 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,
  • Uterine atony
  • Drain placed in the area to be infiltrated,
  • History of drug addiction and psychiatric illness,
  • Understand Visual analog pain scale

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Bupivacain
Group LWI+IPLA will given 30 ml %0,5 bupivacaine+%2 lidocaine infiltration and instillation
Other Names:
  • fentanyl
  • lidocain
Active Comparator: Group morphine ( M )
intrathecal injection of morphine with local anesthesic
Drug: Morphine hydrochloride
Group M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally.
Other Names:
  • Bupivacaine
  • fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively
Time Frame: 2,4,6,12,and 24 hours postoperatively
The VAS is a validated.Possible scores range from 0 (no pain) to 10 (worst possible pain)
2,4,6,12,and 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: ayşenur dostbil, prof, Department of Anesthesiology and Reanimation.Ataturk Universty School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

November 15, 2022

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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