Compared With Different Method for Postcesarean Section Analgesia

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05405049
• Other study ID #: B.30.2.ATA.0.01.00/339
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: June 2022
• Source: Ataturk University
• Contact: nazim dogan, prof
• Phone: 905336365805
• Email: nazdogan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 )

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
Turkey	Atatürk üniversty medicine school	Erzurum	Yakuti?ye

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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