Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
NCT ID: NCT02747628
Last Updated: 2020-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2013-04-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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C group, (n=20)
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.
Placebo
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.
TDN group, (n=20)
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.
transdermal therapeutic system- nicotine.
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.
TDM group, (n=20)
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.
transdermal therapeutic system- melatonin.
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.
Interventions
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Placebo
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.
transdermal therapeutic system- nicotine.
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.
transdermal therapeutic system- melatonin.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Dr.Ibrahim Mamdouh Esmat
Dr.
Other Identifiers
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942
Identifier Type: -
Identifier Source: org_study_id
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