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

NCT06820190 | Recruiting

• 1 other identifier: 36264PR1047/1/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PCA; Idiopathic Scoliosis; Posterior Spinal Fusion; Multiple Mid-Transverse Process to Pleura

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intraoperative fentanyl consumption

  Intraoperatively

• Time to the first request for the rescue analgesia

  24 hours postoperatively

• Total morphine consumption

  24 hours postoperatively

• Mean arterial pressure

  Every 15 minutes until the end of the surgery (Up to 2 hours)

• Heart rate

  Every 15 minutes until the end of the surgery (Up to 2 hours)

Study Arms (2)

MTP group

EXPERIMENTAL

Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.

Other: Multiple Mid-Transverse Process to Pleura (MTP) Block

PCA group

EXPERIMENTAL

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

Interventions

Morphine DRUG

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.

Also known as: PCA

PCA group

Multiple Mid-Transverse Process to Pleura (MTP) Block OTHER

Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.

MTP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Dental Occlusion; Morphine; Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Central Study Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)