Back to resultsUltrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-Guided Transversus Abdominis Plane Block
Morphine
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain focused on measuring Ultrasound-Guided Transversus Abdominis Plane Block, Morphine, Caesarean section
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.
Sites / Locations
- Faculty of Medicine, Sohag University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
transversus abdominis plain block group
intrathecal morphia group
Arm Description
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
intrathecal 150 microgram morphine in a 0.5 ml volume as an adjuvant to spinal anesthesia
Outcomes
Primary Outcome Measures
prevention of post-operative pain
reduction of visual analogue scale post-operative
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05331781
Brief Title
Ultrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section
Official Title
Comparative Study Between Ultrasound-Guided Transversus Abdominis Plane Block and Spinal Morphine for Pain Relief After Elective Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Ultrasound-Guided Transversus Abdominis Plane Block, Morphine, Caesarean section
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transversus abdominis plain block group
Arm Type
Experimental
Arm Description
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
Arm Title
intrathecal morphia group
Arm Type
Experimental
Arm Description
intrathecal 150 microgram morphine in a 0.5 ml volume as an adjuvant to spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Transversus Abdominis Plane Block
Intervention Description
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
Drug
Intervention Name(s)
Morphine
Intervention Description
intrathecal 150 microgram morphine in a 0.5 ml volume will be added to bupivacaine as an adjuvant to spinal anesthesia
Primary Outcome Measure Information:
Title
prevention of post-operative pain
Description
reduction of visual analogue scale post-operative
Time Frame
72 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Medicine, Sohag University
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section
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