- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351253
Erector Spinae Plane Block Versus Lateral Transversus Abdominis Plane Block for Open Abendectomy Surgery
Analgeisc Effect of Erector Spinae Plane Block Versus Lateral Transversus Abdominis Plane Block in Patients Undergoing Open Abendectomy Surgery: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
regional technique according to randomization will be given after induction of general anesthesia Fentanyl boluses of 1 mcg/kg will be given in case of inadequate analgesia. Inadequate analgesia identified by 20% increase in the heart rate and/or systolic blood pressure from baseline measurement.
postoperative analgesia: regular paracetamol 1 g/6 hours (intravenously at first then orally once the oral feeding is resumed) and 75 mg diclofenac (intramuscularly at first then orally once the oral feeding is resumed).
If Numeric rating scale (NRS) is > 3 intravenous titration of 2 mg morphine is given slowly to be repeated after 30 minutes if pain persisted
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maha Mostafa, MD
- Phone Number: +201000365115
- Email: maha.mostafa@cu.edu.eg
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Recruiting
- Cairo University
-
Contact:
- ahmed Shash, Professor
- Phone Number: +201001033999
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult patients, undergoing open appendectomy.
Exclusion Criteria:
- American society of anesthesiologist-physical status >III,
- allergy to any of the study drugs,
- coagulopathy
- local infection,
- history of chronic pain or regular opioid use;
- inability to comprehend the Numeric Rating Scale (NRS),
- pregnant or lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAP group
|
Patient will received TAP block using the lateral approach while in supine position.
A 20 mL of 0.25% bupivacaine will be injected after negative aspiration.
|
|
Active Comparator: ESP group
|
Patients will receive the ESP block at the level of the 10th thoracic (T10) transverse process using a linear 6-13 MHz ultrasound transducer.
A 20 mL of 0.25% bupivacaine will be injected below the muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: from extubation until 24 hours postoperative
|
mg
|
from extubation until 24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numeric rating scale
Time Frame: AT 0.5, 2, 6, 12, and 24 hours postoperative.
|
a scale of 0-10, where 0 means "no pain" and 10 means "worst imaginable pain"
|
AT 0.5, 2, 6, 12, and 24 hours postoperative.
|
|
quality of recovery
Time Frame: 24 hours after suregry
|
assessed using Quality of recovery-15 (QOR-15); Consists of 15 items evaluating five dimensions of health: physical comfort, physical independence, psychological support, emotional state, and pain. Scoring Range: Each item is rated on an 11-point numerical scale (0 to 10). The total score ranges from 0 (extremely poor recovery) to 150 (excellent recovery). |
24 hours after suregry
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-320-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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