Compared With Different Method for Postcesarean Section Analgesia

Ataturk University

Status: Not yet enrolling

Conditions: Analgesia

Treatments: Drug: Bupivacain; Drug: Morphine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05405049

B.30.2.ATA.0.01.00/339

Details and patient eligibility

About

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 )

Full 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

Enrollment: 46 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacain

Group morphine ( M )

Active Comparator group

Description:

intrathecal injection of morphine with local anesthesic

Treatment:

Drug: Morphine hydrochloride