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Completed

NCT Number: NCT05405049

Compared With Different Method for Postcesarean Section Analgesia

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 )

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk üniversty medicine school

Erzurum, YAKUTİYE, 25100, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bupivacaine, fentanyl

Bupivacain

Drug

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

Other names: lidocain, fentanyl

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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