Postoperative Pain Relief
Conditions
Keywords
Transdermal nicotine, Transdermal melatonin, Postoperative pain, Laparoscopic cholecystectomy
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.
Interventions
DRUGPlacebo
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.
DRUGtransdermal 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.
DRUGtransdermal 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A Mean Difference of Total Analgesic (Pethidine) Consumption. | [Time Frame: The total pethidine requirements (mg) 12 hours postop] |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | C Group, (n=20) | TDN Group, (n=20) | TDM Group, (n=20) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 3.39 | 43.1 years STANDARD_DEVIATION 2.4 | 44.3 years STANDARD_DEVIATION 1.86 | 43.2 years STANDARD_DEVIATION 3.2 |
| Duration of anesthesia (min) | 111.2 minutes STANDARD_DEVIATION 3.4 | 112.8 minutes STANDARD_DEVIATION 4.4 | 111.4 minutes STANDARD_DEVIATION 3.78 | 111.8 minutes STANDARD_DEVIATION 3.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Egypt | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 8 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 4 / 20 | 0 / 20 |
Outcome results
Primary
A Mean Difference of Total Analgesic (Pethidine) Consumption.
Time frame: [Time Frame: The total pethidine requirements (mg) 12 hours postop]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C Group, (n=20) | A Mean Difference of Total Analgesic (Pethidine) Consumption. | 122.15 mg | Standard Deviation 6.38 |
| TDN Group, (n=20) | A Mean Difference of Total Analgesic (Pethidine) Consumption. | 55.5 mg | Standard Deviation 3.97 |
| TDM Group, (n=20) | A Mean Difference of Total Analgesic (Pethidine) Consumption. | 59.7 mg | Standard Deviation 4.43 |