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

NCT06331143 | Completed

• 1 other identifier: 36264PR551/2/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Conditions

Mid-Transverse Process Block; Intrathecal Morphine; Idiopathic Scoliosis; Posterior Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  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 Outcomes (4)

• Heart rate

  Till the end of surgery.

• Mean arterial pressure

  Till the end of surgery.

• Patient satisfaction

  24 hours postoperative.

• Complications

  24 hours postoperative.

Study Arms (2)

Mid-Transverse Process block (MTP) group

EXPERIMENTAL

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

Device: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block

Intrathecal morphine (IM) group

EXPERIMENTAL

Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.

Drug: Morphine

Interventions

Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block DEVICE

Patients will receive MTP block after induction of anesthesia.

Mid-Transverse Process block (MTP) group

Morphine DRUG

Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.

Intrathecal morphine (IM) 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:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Dental Occlusion; Morphine

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

Study Officials

• Mohammed S ElSharkawy, MD

  Faculty of Medicine, Tanta University, Tanta, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• 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: March 17, 2024
• First Posted: March 26, 2024
• Study Start: March 28, 2024
• Primary Completion: January 4, 2026
• Study Completion: January 4, 2026
• Last Updated: January 29, 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)