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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05405049
Enrollment
46
Registered
2022-06-03
Start date
2022-06-16
Completion date
2023-11-11
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

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

Interventions

Group M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally.

DRUGBupivacain

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

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.postoperative 24 hoursThe primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.

Secondary

MeasureTime frameDescription
Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively2,4,6,12,and 24 hours postoperativelyThe VAS is a validated.Possible scores range from 0 (no pain) to 10 (worst possible pain)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026