Idiopathic Scoliosis, Intrathecal Morphine, Mid-Transverse Process Block, Posterior Spinal Fusion
Conditions
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.
Interventions
DEVICEUltrasound-Guided Mid-Transverse Process to Pleura (MTP) Block
Patients will receive MTP block after induction of anesthesia.
DRUGMorphine
Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Till the end of surgery. | Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery. |
| Mean arterial pressure | Till the end of surgery. | Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery. |
| Patient satisfaction | 24 hours postoperative. | 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. |
| Complications | 24 hours postoperative. | Complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohammed S ElSharkawy, MD
Faculty of Medicine, Tanta University, Tanta, Egypt.
Outcome results
None listed