Idiopathic Scoliosis, Multiple Mid-Transverse Process to Pleura, PCA, Posterior Spinal Fusion
Conditions
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.
Interventions
OTHERMultiple Mid-Transverse Process to Pleura (MTP) Block
Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.
DRUGMorphine
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
Countries
Egypt
Contacts
Primary ContactMohammed S Elsharkawy, MD
Outcome results
None listed