Postoperative PainNCT02726126
Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief
An observational study of Postoperative Pain, run by Ain Shams University.
Trial summary
Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study was designed to be a randomized, placebo-controlled, double-blind parallel study in which the patients, investigators, anesthesiologists and the surgeons were blinded to the given treatment. This study was conducted in Ain-Shams university hospitals, from March 2013 to April 2015 on 75 patients aged between 18 and 50 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm undergoing elective single level lumber laminectomy under general anesthesia. The study protocol was approved from the institutional ethical committee and written informed consent was obtained from all the patients.
Who may be able to join
- 75 patients aged between 18 and 50 years old
- Both sex of ASA physical status I and II
- 70-90 kg body weight
- Height 160-180 cm
- Undergoing elective single level lumber laminectomy under general anesthesia.
Who cannot join
- Patients with impaired kidney or liver functions
- History of cardiac or central nervous system disease
- 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 or allergy to the used medications
Show all 9Show fewer
- Coagulation defect
- Local infection at the site of application of transdermal patch
- Patient refusal or duration of surgery more than 120 minutes were excluded from the study.
About this study
Official title: Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial
Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). 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) postoperatively were also assessed.
- Conditions
- Postoperative Pain
- Being tested
- Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy
- Keywords
- Transdermal fentanyl, Transdermal melatonin, Postoperative pain, lumber laminectomy, Relief
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomyDrug
| Study group | Role | What they receive |
|---|---|---|
| C group, (n=25) | C group, (n=25) each patient received transdermal placebo patch Receives: Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy | |
| TDF group, (n=25) | TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h Receives: Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy | |
| TDM group, (n=25) | TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin Receives: Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A mean difference of total analgesic (pethidine) consumption.
Measured: The total pethidine requirements (mg) 12 hours postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726126
- Sponsor's protocol ID
- 915
- Status last verified
- Apr 2016
- First submitted
- 29 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02726126
- Acronym / sponsor ID
- 915
- Conditions
- Postoperative Pain
- Keywords
- Transdermal fentanyl, Transdermal melatonin, Postoperative pain, lumber laminectomy, Relief
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). 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) postoperatively were also assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C group, (n=25) | – | Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomyC group, (n=25) each patient received transdermal placebo patch |
| TDF group, (n=25) | – | Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomyTDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h |
| TDM group, (n=25) | – | Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomyTDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study was designed to be a randomized, placebo-controlled, double-blind parallel study in which the patients, investigators, anesthesiologists and the surgeons were blinded to the given treatment. This study was conducted in Ain-Shams university hospitals, from March 2013 to April 2015 on 75 patients aged between 18 and 50 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm undergoing elective single level lumber laminectomy under general anesthesia. The study protocol was approved from the institutional ethical committee and written informed consent was obtained from all the patients.
Key inclusion criteria (5 listed)
- 75 patients aged between 18 and 50 years old
- Both sex of ASA physical status I and II
- 70-90 kg body weight
- Height 160-180 cm
- Undergoing elective single level lumber laminectomy under general anesthesia.
Key exclusion criteria (9 listed)
- Patients with impaired kidney or liver functions
- History of cardiac or central nervous system disease
- History of drug or alcohol abuse
- History of chronic pain or daily intake of analgesics
- Uncontrolled medical disease (diabetes mellitus and hypertension)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy | Drug | C group, (n=25), TDF group, (n=25), TDM group, (n=25) |
Primary outcome
A mean difference of total analgesic (pethidine) consumption.
Time frame: The total pethidine requirements (mg) 12 hours postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A mean difference of total analgesic (pethidine) consumption. (time frame: The total pethidine requirements (mg) 12 hours postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.