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

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT05331781

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Ultrasound-Guided Transversus Abdominis Plane Block Drug: Morphine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparative Study Between Ultrasound-Guided Transversus Abdominis Plane Block and Spinal Morphine for Pain Relief After Elective Caesarean Section

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
Experimental: intrathecal morphia group intrathecal 150 microgram morphine in a 0.5 ml volume as an adjuvant to spinal anesthesia	Drug: Morphine intrathecal 150 microgram morphine in a 0.5 ml volume will be added to bupivacaine as an adjuvant to spinal anesthesia

Arm

Intervention/Treatment

Experimental: 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

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

Experimental: intrathecal morphia group

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

Drug: Morphine

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

Outcome Measures

Primary Outcome Measures

prevention of post-operative pain [72 hours]
reduction of visual analogue scale post-operative

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Sohag University	Sohag		Egypt

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Islam Mokhtar Ahmed, lecturer of anesthesia and intensive care, Sohag University

ClinicalTrials.gov Identifier:

NCT05331781

Other Study ID Numbers:

soh-Med-22-2-41

First Posted:

Apr 18, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Islam Mokhtar Ahmed, lecturer of anesthesia and intensive care, Sohag University

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

Additional relevant MeSH terms:

Pain, Postoperative

Morphine

Study Results

No Results Posted as of Apr 18, 2022