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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05331781
Other study ID # soh-Med-22-2-41
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date February 1, 2022

Study information

Verified date April 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This interventional double-blind randomized controlled study was carried out on 60 cases underwent elective caesarean section delivery, they were divided into 2 groups; patients were randomly allocated into two equal groups; Group M: received intrathecal 150 microgram morphine in a 0.5 ml volume, mixed with 10 mg of hyperbaric bupivacaine 0.5 % in a 2 ml volume (total volume 2.5 ml). Group B: received intrathecal 10 mg hyperbaric bupivacaine 0.5% 2ml volume + 0.5 saline (Total volume 3ml) and at the end of surgery patient received bilateral TAP block with 20 ml volume of 0.25% bupivacaine on each side.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 1, 2022
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria: - pregnant females scheduled for elective cesarean section Exclusion Criteria: - Patient refusal Patients with known allergies or with past history of allergy to local anesthesia Patients having an infection at the site of injection either in the back or in the abdominal region, Patients with coagulopathy or on systemic anticoagulation, Chronic opioid abuse, significant neurological, psychiatric or neuromuscular disease, Drug abuse and alcoholism, Obesity (BMI 30 and higher), Cardiovascular disease and Endocrine disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound-Guided Transversus Abdominis Plane Block
patient in the supine position, ultrasound will be used to identify the plane between the internal oblique and transversus abdominis muscle to inject 20 ml of local anesthetic for each side
Drug:
Morphine
intrathecal 150 microgram morphine in a 0.5 ml volume will be added to bupivacaine as an adjuvant to spinal anesthesia

Locations

Country Name City State
Egypt Faculty of Medicine, Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevention of post-operative pain reduction of visual analogue scale post-operative 72 hours
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