- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06331143
Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion
Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.
Intrathecal opioids have been used to manage postoperative pain in pediatric patients for a wide variety of surgeries , including adolescent and adult PSF. Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief.
The mid-transverse process to pleura (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetics (LAs) are administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament at the level of injection, and frequently to adjacent levels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ElGharbia
-
Tanta, ElGharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
Exclusion Criteria:
- Patient with morbid obesity (body mass index >40 kg/m2).
- Patients with pre-existing infection at block site.
- Known allergy to study drugs.
- Coagulation disorder.
- History of psychiatric illness.
- Pre-existing neurological deficits.
- Presence of any pre-operative pain or history of chronic pain.
- History of regular analgesic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mid-Transverse Process block (MTP) group
Patients will receive mid-transverse process to pleura (MTP) block after induction of anesthesia.
|
Patients will receive MTP block after induction of anesthesia.
|
|
Experimental: Intrathecal morphine (IM) group
Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.
|
Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperative
|
Degree of pain will be assessed by the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively. |
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: Till the end of surgery.
|
Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
|
Till the end of surgery.
|
|
Mean arterial pressure
Time Frame: Till the end of surgery.
|
Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
|
Till the end of surgery.
|
|
Patient satisfaction
Time Frame: 24 hours postoperative.
|
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied). It will be assessed 24 hours after surgery. |
24 hours postoperative.
|
|
Complications
Time Frame: 24 hours postoperative.
|
Complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.
|
24 hours postoperative.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammed S ElSharkawy, MD, Faculty of Medicine, Tanta University, Tanta, Egypt.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Musculoskeletal Diseases
- Spinal Diseases
- Bone Diseases
- Spinal Curvatures
- Scoliosis
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Heterocyclic Compounds, 4 or More Rings
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Digestive System and Oral Physiological Phenomena
- Morphine Derivatives
- Dentistry
- Dental Physiological Phenomena
- Morphine
- Dental Occlusion
Other Study ID Numbers
- 36264PR551/2/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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