1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [anjujacob101@gmail.com].
   


6. For how long will this data be available start date provided 26-08-2024 and end date provided 24-08-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage (definition by IASP). There are four major types of pain, nociceptive pain (due to tissue injury), inflammatory pain, neuropathic pain (due to nerve irritation) functional pain (due to no obvious origin). Pain has seven dimensions or core aspects: physical, sensory, behavioral, socio-cultural, cognitive, affective, and spiritual. Lumbar spine surgery is routinely performed in patients for various indications to mitigate back pain, lessen neurological symptoms, and improve mobility. The major indications broadly include trauma, infection, malignancy, congenital, and degenerative disease. It is known to be a major surgical procedure associated with severe postoperative pain requiring comprehensive management . Poorly managed postoperative analgesia culminates into delayed mobilization, prolonged hospital stay, morbidity and delayed rehabilitation. There is growing evidence that acute post-operative pain also influences the development of chronic pain through central or peripheral sensitization of receptors. Recently, enhanced recovery programs necessitate satisfactory analgesia and a number of modalities ranging from nonsteroidal anti-inflammatory drugs, opioids, and local anaesthetics have been used. Multimodal analgesia is an invaluable tool for escalating recovery. One of the methods for post-operative analgesia that has gained popularity in recent years is the intrathecal opioid administration in which opioid is directly injected into cerebrospinal fluid and acts directly on the opioid receptors present in the substantia gelatinosa and inhibit presynaptic and postsynaptic nociceptive transmission without sympathetic effects. Morphine, the prototypical opioid, has been the most widely accepted for intrathecal administration. Intrathecal morphine has a good role in post-operative pain management as it produces segmental analgesia, which causes localized nociception without sensory, motor, autonomic, or systemic side effects. However, it is associated with various side effects in postoperative period such as pruritus, somnolence, respiratory depression, vomiting and urinary retention. This makes it imperative that the dose of opioids needs to be attenuated to avoid unwanted side effects that impede recovery. Preemptive analgesia entails adopting techniques prior to pain registration in the central neurons and further amplification. The onset of action of morphine starts from 30-60 minutes and it can last for about 4-24 Hours. Local anaesthetic drugs such as ropivacaine have been used for spinal anaesthesia in spine surgeries and have immediate onset of action. Anesthesiologists have been combining local anesthetic (bupivacaine) with morphine so as to reduce its dose. Intrathecal morphine in combination with local anesthetic is an emerging technique wherein the onset of analgesia is immediate and dose of morphine may be further reduced, providing preventive analgesia. Hence we designed this study to compare the analgesic efficacy of 0.2% ropivacaine plus 200 mcg of intrathecal morphine with 200 mcg of intrathecal morphine in posterior lumbar spine surgery.

RESEARCH QUESTION OF THE STUDY - To determine whether adding ropivacaine to low dose intrathecal morphine provides superior analgesia as compared to intrathecal morphine alone in patients undergoing lumbar spine surgeries?