Tokyo, March 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060941) titled 'A Study on Using Low-Dose Morphine During Complex Lower Back Surgery' on March 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - King Abdullah Medical City

Condition: Condition - Pain after complex spine surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - to test that low-dose ITM would significantly reduce perioperative systemic opioid consumption, improve pain scores, and increase patient satisfaction, without a significant increase in opioid-related adverse effects Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention Group: Low-dose Intrathecal Morphine (ITM)

Amount: 0.2 mg preservative-free morphine in 2 ml normal saline. Route: Intrathecal injection at lumbar vertebral level L2-L3 using a 25 G pencil point spinal needle. Frequency: Administered once after the induction of general anesthesia and prior to positioning for surgery. Duration/Standard Care: Single intrathecal administration. Patients also receive standard general anesthesia. Prior to surgical closure, patients receive standardized multimodal analgesia (1 g IV paracetamol, 8 mg IV meloxicam, and subfascial infiltration with 20 ml of 0.5% bupivacaine). Postoperatively, patients are prescribed intravenous morphine patient-controlled analgesia (PCA) set at a 1 mg/ml concentration, delivering 1 mg boluses with a 10-minute lockout interval (maximum of 24 mg/4 hours). Interventions/Control_2 - Active Control Group: General Anesthesia Only (Control)

Amount/Route: Standard general anesthesia without any intrathecal intervention. Frequency: Administered continuously for the duration of the surgery. Duration/Standard Care: Patients in this group are turned to the prone position immediately after induction without receiving intrathecal medication. Prior to surgical closure, they receive the exact same standardized multimodal analgesia as the ITM group: 1 g IV paracetamol, 8 mg IV meloxicam, and subfascial infiltration with 20 ml of 0.5% bupivacaine. Postoperatively, they are also prescribed identical intravenous morphine patient-controlled analgesia (PCA) with 1 mg boluses and a 10-minute lockout interval for the first 48 hours.

Eligibility: Age-lower limit - 8 years-old = Gender - Male and Female Key inclusion criteria - American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective lumbar spine surgery involving two or more levels Key exclusion criteria - Exclusion criteria included refusal to participate, single-level procedure, minimally invasive, or revision surgery, history of hepatic or renal impairment, any contraindication to intrathecal injection (e.g., coagulopathy, local infection), known allergy to morphine and history of chronic opioid use or dependence Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2023 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2027 Year 05 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069738

Disclaimer: Curated by HT Syndication.