CTRI/2025/08/092868Not yet recruitingNot Applicable
Effect of noise cancellation headphones during total hip arthroplasty under spinal anaesthesia on postoperative pain; a randomized trial controlled study
Maulana Azad Medical College1 site in 1 country70 target enrollmentStarted: September 1, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Maulana Azad Medical College
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Difference between mean of highest pain scores in the first 24 hours after surgery, measured using a 11-point numeric rating scale (NRS)in both groups.
Study Overview
Brief Summary
Single-blind, randomized controlled pilot study of 70 adults undergoing elective total hip arthroplasty under spinal anaesthesia to assess the effect of noise-cancellation headphones on postoperative pain. Primary outcome: highest NRS pain score in first 24 h. Secondary outcomes: pain scores at set intervals, time to first analgesic, total analgesic use, sensory/motor block duration, QoR-15 at 24 h, and intraoperative sedation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 18 to 65 years with American Society of Anaesthesiologists (ASA) physical status I to III.
Exclusion Criteria
- •Patients with hearing impairment or use of hearing aids; chronic pain syndromes or regular opioid analgesic use in the last three months; neurological disorders including dementia, Parkinson’s disease, or stroke; psychiatric illness such as major depression, schizophrenia, or severe anxiety; contraindications to spinal anaesthesia such as coagulopathy, infection at injection site, or spinal deformities; BMI greater than 35 kg/m²; uncontrolled cardiovascular disease such as severe hypertension, recent myocardial infarction, or heart failure.
Outcomes
Primary Outcomes
Difference between mean of highest pain scores in the first 24 hours after surgery, measured using a 11-point numeric rating scale (NRS)in both groups.
Time Frame: First 24 hours after surgery.
Secondary Outcomes
- Mean post operative pain scores using NRS at 4, 8, 12, and 24 hours after surgery.(4, 8, 12, and 24 hours after surgery.)
- Mean time to requirement of first postoperative analgesic.(Within first 24 hours after surgery.)
- Mean analgesic consumption over first 24 hrs postoperatively.(First 24 hours after surgery.)
- Mean duration of sensory blockade and motor blockade of spinal anaesthesia.(From administration of spinal anaesthesia until complete recovery of sensory and motor function.)
- Mean quality of Recovery -15 (QoR- 15) scores at 24 hours.(24 hours after surgery.)
- Mean intraoperative Bispectral Index Scores (BIS).(During intraoperative period.)
Investigators
Arun Prasannan
Maulana Azad Medical College
Study Sites (1)
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