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

NCT05331781 | Completed DMC

• 1 other identifier: soh-Med-22-2-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasound-Guided Transversus Abdominis Plane Block, Morphine, Caesarean section

Outcome Measures

Primary Outcomes (1)

• prevention of post-operative pain

  reduction of visual analogue scale post-operative

  72 hours

Study Arms (2)

transversus abdominis plain block group

EXPERIMENTAL

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

Procedure: Ultrasound-Guided Transversus Abdominis Plane Block

intrathecal morphia group

EXPERIMENTAL

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

Drug: Morphine

Interventions

Ultrasound-Guided Transversus Abdominis Plane Block 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

transversus abdominis plain block group

Morphine DRUG

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

intrathecal morphia group

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant females scheduled for elective cesarean section

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine, Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 18, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)