Back to resultsTransdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Primary Purpose
Postoperative Pain Relief
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
transdermal therapeutic system- nicotine.
transdermal therapeutic system- melatonin.
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain Relief focused on measuring Transdermal nicotine, Transdermal melatonin, Postoperative pain, Laparoscopic cholecystectomy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
C group, (n=20)
TDN group, (n=20)
TDM group, (n=20)
Arm Description
C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
Outcomes
Primary Outcome Measures
A Mean Difference of Total Analgesic (Pethidine) Consumption.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02747628
Brief Title
Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Official Title
Comparative Study Between Transdermal Nicotine and Melatonin Patches on Postoperative Pain Relief After Laparoscopic Cholecystectomy, a Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Relief
Keywords
Transdermal nicotine, Transdermal melatonin, Postoperative pain, Laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C group, (n=20)
Arm Type
Placebo Comparator
Arm Description
C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
Arm Title
TDN group, (n=20)
Arm Type
Active Comparator
Arm Description
TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
Arm Title
TDM group, (n=20)
Arm Type
Active Comparator
Arm Description
TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
Intervention Type
Drug
Intervention Name(s)
transdermal therapeutic system- nicotine.
Other Intervention Name(s)
TDN, Nicorette® invisi 15mg /16hr.
Intervention Description
Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
Intervention Type
Drug
Intervention Name(s)
transdermal therapeutic system- melatonin.
Other Intervention Name(s)
TDM, melatonin sleep patch from Respro Labs ™ (7 mg/8hr).
Intervention Description
Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
Primary Outcome Measure Information:
Title
A Mean Difference of Total Analgesic (Pethidine) Consumption.
Time Frame
[Time Frame: The total pethidine requirements (mg) 12 hours postop]
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
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