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Clinical Trials/NCT06331143
NCT06331143
Completed
Not Applicable

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

Tanta University1 site in 1 country40 target enrollmentMarch 28, 2024

Overview

Phase
Not Applicable
Intervention
Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block
Conditions
Mid-Transverse Process Block
Sponsor
Tanta University
Enrollment
40
Locations
1
Primary Endpoint
Degree of pain
Status
Completed
Last Updated
3 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2024
End Date
January 4, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

Eligibility Criteria

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.

Arms & Interventions

Mid-Transverse Process block (MTP) group

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

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

Intrathecal morphine (IM) group

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

Intervention: Morphine

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (1)

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