Ultrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section

NCT ID: NCT05331781

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-02-01

Brief 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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

transversus abdominis plain block group

post-cesarean section tap block will be given by ultrasound guidance using 20 ml bupivacaine local anesthetic 0.25% concentration for each side as an adjuvant to spinal anesthesia

Group Type: EXPERIMENTAL

Ultrasound-Guided Transversus Abdominis Plane Block

Intervention Type: PROCEDURE

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

intrathecal morphia group

intrathecal 150 microgram morphine in a 0.5 ml volume as an adjuvant to spinal anesthesia

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

intrathecal 150 microgram morphine in a 0.5 ml volume will be added to bupivacaine as an adjuvant to spinal anesthesia

Interventions

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

Intervention Type: PROCEDURE

Morphine

intrathecal 150 microgram morphine in a 0.5 ml volume will be added to bupivacaine as an adjuvant to spinal anesthesia

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Islam Mokhtar Ahmed

lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Sohag University

Sohag, , Egypt

Countries

Egypt

Other Identifiers

soh-Med-22-2-41

Identifier Type: -

Identifier Source: org_study_id