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NCT Number: NCT06820190

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Saad A Moharam, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multiple Mid-Transverse Process to Pleura (MTP) Block

Other

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

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.

Other names: PCA

Primary outcomes

  1. Degree of pain

    Time frame: 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 outcomes

  1. Intraoperative fentanyl consumption

    Time frame: 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).

  2. Time to the first request for the rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).

  3. Total morphine consumption

    Time frame: 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.

  4. Mean arterial pressure

    Time frame: 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.

  5. Heart rate

    Time frame: 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.

  6. Degree of patient satisfaction

    Time frame: 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.

  7. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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