Compared With Different Method for Postcesarean Section Analgesia

NCT05405049 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/339
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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 )

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

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

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

  postoperative 24 hours

Secondary Outcomes (1)

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

  2,4,6,12,and 24 hours postoperatively

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Bupivacain

Group morphine ( M )

ACTIVE COMPARATOR

intrathecal injection of morphine with local anesthesic

Drug: Morphine hydrochloride

Interventions

Morphine hydrochloride DRUG

Group M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally.

Also known as: Bupivacaine, fentanyl

Group morphine ( M )

Bupivacain DRUG

Group LWI+IPLA will given 30 ml %0,5 bupivacaine+%2 lidocaine infiltration and instillation

Also known as: lidocain, fentanyl

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• age
• ASA II
• Fullterm singular pregnancy

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk üniversty medicine school

Erzurum, YAKUTİYE, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ayşenur dostbil, prof

  Department of Anesthesiology and Reanimation.Ataturk Universty School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: June 16, 2022
• Primary Completion: October 25, 2023
• Study Completion: November 11, 2023
• Last Updated: January 12, 2026

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)