Compared With Different Method for Postcesarean Section Analgesia

Not Applicable

• Conditions: Analgesia
• Interventions: Drug: Bupivacain; Drug: Morphine hydrochloride

• Registration Number: NCT05405049
• Lead Sponsor: Ataturk University

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 )

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 Timeline

• Study First Submitted: 2022-05-24
• Status Verified: 2022-06
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-03
• Last Update Posted: 2022-06-03
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI)	Bupivacain	local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation
Group morphine ( M )	Morphine hydrochloride	intrathecal injection of morphine with local anesthesic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Atatürk üniversty medicine school; 🇹🇷 Erzurum, Yakuti̇ye, Turkey