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

Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331143
• Other study ID #: 36264PR551/2/24
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: Mohammed S ElSharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Intrathecal Morphine
• Posterior Spinal Fusion
• Scoliosis

Intervention

Device:
• Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block
Patients will receive MTP block after induction of anesthesia.

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	ElGharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery.
Secondary	Mean arterial pressure	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.
Secondary	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 postoperative.
Secondary	Complications	Complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.	24 hours postoperative.