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Effect of Nicotine Replacement Therapy on abstinent smokers undergoing spine surgery

EFFECT OF NICOTINE REPLACEMENT THERAPY ON PERI-OPERATIVE OPIOID REQUIREMENT IN ABSTINENT TOBACCO SMOKERS UNDERGOING SPINAL SURGERY: A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027664
Enrollment
100
Registered
2020-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M498- Spondylopathy in diseases classified elsewhere

Interventions

Intervention1: Nicotine patch: Nicotine patch will be administered from one day prior to surgery by the principal investigator over the non hairy area of the upper limb or shoulder every 24 hours till

Sponsors

Dr Puneet Khanna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Posted for spinal fusion surgery or discectomy •History of active smoking (at least one cigarette per day) •ASA I and ASA II.

Exclusion criteria

Exclusion criteria: •Refusal to consent •Body mass index (BMI) > 30 kg/m2; •Any present or past history suggestive of cardiovascular diseases (excluding hypertensive patients well controlled on treatment), hepatic dysfunction or renal dysfunction •Any present or past history suggestive of acute or chronic pain or intake of any medication known to affect pain thresholds; •History of drug abuse

Design outcomes

Primary

MeasureTime frame
â?¢To estimate the total morphine consumption in patients administered with nicotine patch ( Group A) and patients without nicotine patch (Group B) at the end of 24 hours in patients undergoing spinal fusion surgery or discectomy. â?¢To assess pain scores at rest and movement at 0, 6, 12 and 24 hours in the postoperative period. â?¢To correlate the blood nicotine levels measured a day before surgery and 24 hours after surgery with post-operative morphine consumption. Timepoint: â?¢To estimate the total morphine consumption in patients administered with nicotine patch ( Group A) and patients without nicotine patch (Group B) at the end of 24 hours in patients undergoing spinal fusion surgery or discectomy. â?¢To assess pain scores at rest and movement at 0, 6, 12 and 24 hours in the postoperative period. â?¢To correlate the blood nicotine levels measured a day before surgery and 24 hours after surgery with post-operative morphine consumption.

Secondary

MeasureTime frame
â?¢To compare the adverse effects of opioids in both the groups such as hypoxia, respiratory depression, sedation, pruritis, ileus, urinary retention, nausea and vomiting etc. â?¢To assess the adverse effects of nicotine replacement therapy such as tachycardia, arrhythmias or myocardial ischemia etc. Timepoint: 1. Side effects of morphine -24 hours after surgery 2. Side effects of nicotine - one day before surgery to 48 hours after surgery

Countries

India

Contacts

Public ContactDr Puneet Khanna

All India Institute of Medical Sciences

k.punit@yahoo.com9873106516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026