Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion

Comparison of Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial

This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Scoliosis; Posterior Spinal Fusion; PCA; Multiple Mid-Transverse Process to Pleura
• Intervention / Treatment: Other: Multiple Mid-Transverse Process to Pleura (MTP) Block; Drug: Morphine

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.

Regional anesthesia techniques, mainly epidural analgesia and, more recently, paravertebral blocks, became crucial parts of the multimodal analgesia (MMA) regimen after introducing ultrasound (US) in the regional anesthesia practice. Erector spinae plane (ESP) block and mid-transverse to pleura (MTP) block are the latest developments in postoperative pain therapy.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Principal Investigator: Saad A Moharam, MD
      • Contact: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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:

• Patients with pre-existing infection at block site.
• Known allergy to study drugs.
• Coagulation disorder.
• History of psychiatric illness.
• Pre-existing neurological deficits.
• Patient with morbid obesity (body mass index >40 kg/m2).
• 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTP group; Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.	Other: Multiple Mid-Transverse Process to Pleura (MTP) Block; Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.
Experimental: PCA group; Patients will receive IV-PCA. Morphine is generally administered as an initial loading dose of 0.05-0.1 mg/kg before the end of surgery, with PCA settings of a bolus dose of 0.01-0.03 mg/kg, a lockout interval of 6-10 min, and a background infusion of 0.01-0.02 mg/kg/h.	Drug: Morphine; Patients will receive IV-PCA. Morphine is generally administered as an initial loading dose of 0.05-0.1 mg/kg before the end of surgery, with PCA settings of a bolus dose of 0.01-0.03 mg/kg, a lockout interval of 6-10 min, and a background infusion of 0.01-0.02 mg/kg/h.; Other Names: PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	The degree of pain will be assessed using the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).	Intraoperatively
Time to the first request for the rescue analgesia	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).	24 hours postoperatively
Total morphine consumption	Postoperative analgesia was provided by morphine (3 mg IV in Multiple Mid-Transverse Process to Pleura (MTP) Block group or 0.01 mg/kg bolus with a 15-min lockout in PCA group) to keep the Visual Analogue Scale (VAS) at rest less than 4.	24 hours postoperatively
Mean arterial pressure	Mean arterial pressure will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.	Every 15 minutes until the end of the surgery (Up to 2 hours)
Heart rate	Heart rate will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.	Every 15 minutes until the end of the surgery (Up to 2 hours)
Degree of patient satisfaction	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 postoperatively
Incidence of complications	Incidence of complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Immunologic Techniques; Digestive System and Oral Physiological Phenomena; Morphine Derivatives; Dentistry; Dental Physiological Phenomena; Immunologic Tests; Skin Tests; Immune System Phenomena; Antigen-Antibody Reactions; Morphine; Dental Occlusion; Passive Cutaneous Anaphylaxis
• Other Study ID Numbers: 36264PR1047/1/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No