Comparison of Intrathecal Morphine and Fentanyl in Postoperative Pain Management of Spine Surgeries

Comparison of Intrathecal Morphine and Fentanyl in Postoperative Pain of Spine Surgeries

This is a two arm double-blinded parallel group randomized trial including two groups of intrathecal morphine and intrathecal fentanyl group. The sample size in each group is 40 and a simple randomization will be used, utilizing a random sequence through random number generator software.

The study will be conducted at the neurospine surgery department of Shahid Bahonar Hospital, the main referral neurospine center in Kerman, southeast Iran. The participants and outcome assessors will be blinded to the treatment assignment (morphine or fentanyl).

Inclusion criteria: Candidates for spine surgeries aged between 18 and 85 years and with American Society of Anesthesia (ASA) classification I or II. Exclusion criteria: Pregnant or breastfeeding individuals, patients with a history of allergy to local anesthetic agents, history of cardiac or renal failure, opioid use disorder, uncontrolled blood pressure, body mass index above 40 kg/m2 and a heart rate less than 50 beats/min, patients with spinal cord injuries that could interfere with the pain assessment, patients with incidental durotomy

intrathecal morphine (0.2 mg), intrathecal fentanyl (25 µg)

The primary outcome will be the postoperative pain in 4, 6, 12, and 18 hours post-surgery. The secondary outcome will be the time interval from the surgical procedure until the patient required supplementary analgesics (specifically, intramuscular ketorolac) in addition to postoperative side effects.

A simple randomization will be used utilizing a computer-generated randomization sequence to assign participants into two groups (morphine or fentanyl). Accordingly, by using random number generator, a random sequence is created including numbers 1 and 2 (so that there are equal numbers in each group as the calculated sample size) and based on that, every patient who meets the criteria of the study will be assigned to one of two study groups.

Both participants and the research team who were in charge of the assessment of the outcomes will be blinded to the treatment assignment. Due to the fact that drug injection is performed during surgery and under anesthesia, patients are automatically blinded to the type of treatment. The person who is responsible for evaluating the outcomes will also be blinded regarding the type of treatment, so that the outcome assessor will not be informed about the type of treatment (morphine/fentanyl). The outcome assessor is a neurosurgery resident who measures the outcomes of the study.

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