Phase 4
Completed N=60
Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Postoperative Pain Relief
Source: ClinicalTrials.gov NCT02747628 ↗
Enrolled (actual)
60
Serious AEs
6.7%
Results posted
Aug 2020
Primary outcomePrimary: A Mean Difference of Total Analgesic (Pethidine) Consumption. — 122.15; 55.5; 59.7 mg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Mean Difference of Total Analgesic (Pethidine) Consumption. |
122.15; 55.5; 59.7 | — |
Eligibility Criteria
Inclusion Criteria
- 60 female patients.
- non-smoker patients.
- aged between 18 and 50 years old.
- ASA physical status I and II.
- 70-90 kg body weight and height 160-180 cm.
- undergoing elective laparoscopic cholecystectomy under general anesthesia.
Exclusion Criteria
- Patients with impaired kidney or liver functions.
- history of cardiac or central nervous system disease.
- history of smoking.
- history of drug or alcohol abuse.
- history of chronic pain or daily intake of analgesics.
- uncontrolled medical disease (diabetes mellitus and hypertension).
- history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery.
- allergy to the used medications.
- coagulation defect.
- local infection at the site of application of transdermal patch.
- patient's refusal.
- duration of surgery more than 120 minutes.
Data sourced from ClinicalTrials.gov (NCT02747628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.