Compared With Different Method for Postcesarean Section Analgesia

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: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Bupivacain; Drug: Morphine hydrochloride

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 (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • YAKUTİYE
    • Erzurum, YAKUTİYE, Turkey (Türkiye), 25100
      • Atatürk üniversty medicine school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): October 25, 2023
• Study Completion (Actual): November 11, 2023

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 (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Bupivacaine; Fentanyl
• 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