This study aims to compare two medications, dexmedetomidine and fentanyl, when used alongside a commonly used spinal anesthetic called bupivacaine in patients undergoing lower limb surgery. The main focus of the study is to see which combination causes fewer problems with urination after surgery - a condition known as postoperative urinary retention (POUR). POUR can lead to discomfort, delayed recovery, and a need for catheterization. Dexmedetomidine is a newer drug that may help reduce this problem compared to fentanyl, which is more commonly used but may increase the risk of urinary retention. This trial will help determine which medication combination provides better pain relief while reducing urinary side effects. The study is being conducted as a randomized, double-blind trial at a hospital in Nepal and will include 190 adult patients.
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Adults aged 18 to 60 years
Scheduled for elective lower limb surgery under spinal anesthesia
Classified as American Society of Anesthesiologists (ASA) physical status II or III
Minimum height of 150 cm (to ensure uniform drug volume)
Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site, hemodynamic instability)
Known allergy or hypersensitivity to bupivacaine, fentanyl, or dexmedetomidine
Chronic pain conditions or long-term opioid use
Neurological, Cardiac, Renal, or uncontrolled diabetic conditions
Parallel
Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine
DrugIntervention 1: Intrathecal Dexmedetomidine with Bupivacaine Detailed Description: This intervention consists of a single intrathecal injection of 10 micrograms of dexmedetomidine combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anaesthesia for lower limb surgery. The total volume administered is 3.5 mL. Dexmedetomidine is an alpha-2 non-opioid adjuvant used as a spinal adjuvant for enhancing analgesia
Intervention 2: Intrathecal Fentanyl with Bupivacaine
DrugThis intervention consists of a single intrathecal injection of 25 micrograms of fentanyl combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anesthesia for lower limb surgery. The total volume administered is 3.5 mL. Fentanyl is a lipophilic opioid commonly used as a spinal adjuvant for enhancing analgesia. This arm is being compared with dexmedetomidine to evaluate differences in POUR incidence, analgesic effectiveness, and side effect profiles.
Incidence of Postoperative Urinary Retention (POUR) at the 3rd Postoperative Hour
The primary outcome is the number of participants who are unable to void urine at the 3rd postoperative hour with a urinary bladder (UB) volume of ≥600 mL, confirmed by bladder ultrasound. Participants meeting this criterion will be considered to have postoperative urinary retention and will undergo in-out catheterization.
Requirement of Urinary Catheterization at 6th Postoperative Hour
Number of participants unable to void urine by the 6th postoperative hour, requiring insertion of a Foley's catheter.
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