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Compared With Different Method for Postcesarean Section Analgesia

Sponsor
Ataturk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05405049
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
5.5
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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 )

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

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:
  • lidocain
  • fentanyl

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atatürk üniversty medicine school Erzurum Yakuti̇ye Turkey 25100

    Sponsors and Collaborators

    • Ataturk University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aysenur Dostbil, Clinical Professor, Ataturk University
    ClinicalTrials.gov Identifier:
    NCT05405049
    Other Study ID Numbers:
    • B.30.2.ATA.0.01.00/339
    First Posted:
    Jun 3, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Agnosia
    Lidocaine
    Fentanyl
    Morphine
    Bupivacaine

    Study Results

    No Results Posted as of Jun 3, 2022