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

Not Applicable

Recruiting

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

• Registration Number: NCT06820190
• Lead Sponsor: Tanta University

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Study Start: 2025-02-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTP group	Multiple Mid-Transverse Process to Pleura (MTP) Block	Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.
PCA group	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.

Primary Outcome Measures

Name	Time	Method
Degree of pain	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperatively	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).
Time to the first request for the rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Total morphine consumption	24 hours postoperatively	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.
Mean arterial pressure	Every 15 minutes until the end of the surgery (Up to 2 hours)	Mean arterial pressure will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.
Heart rate	Every 15 minutes until the end of the surgery (Up to 2 hours)	Heart rate will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.
Degree of patient satisfaction	24 hours postoperatively	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.
Incidence of complications	24 hours postoperatively	Incidence of complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt