Post Laparotomy Pain TreatmentNCT01828840
A Prospective Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia
A study testing epidural morphine via PCEA, epidural fentanyl via PCEA and epidural methadone via PCEA in people with Post Laparotomy Pain Treatment, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post Laparotomy Pain Treatment
- What is being tested?
- epidural morphine via PCEA, epidural fentanyl via PCEA and epidural methadone via PCEA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to 1 Dec 2016
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparotomy
Who cannot join
- Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception
- Illicit drug abusers
- Chronic use of pain medication
- Inability to understand consent form
- Age < 18
- Renal failure (Clcr<50 ml/min)
Show all 10Show fewer
- Chronic use of drugs that can alter plasma levels and\or effect of the study drugs
- Corrected Q-T interval(QTc)=450msc and above
- Contra-indication for epidural catheter insertion
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.
The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.
- Conditions
- Post Laparotomy Pain Treatment
- Being tested
- epidural morphine via PCEA, epidural fentanyl via PCEA, epidural methadone via PCEA, intravenous morphine via PCA
- Keywords
- morphine, fentanyl, methadone, epidural, intravenous, pain, analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural morphine via PCEADrug
epidural fentanyl via PCEADrug
epidural methadone via PCEADrug
intravenous morphine via PCADrug
| Study group | Role | What they receive |
|---|---|---|
| morphine, epidural | Active comparator | Epidurally administrated morphine Receives: Drug: epidural morphine via PCEA |
| fentanyl, epidural | Active comparator | epidurally administrated fentanyl Receives: Drug: epidural fentanyl via PCEA |
| methadone, epidural | Active comparator | epidurally administrated methadone Receives: Drug: epidural methadone via PCEA |
| morphine, intervenous | Active comparator | intravenously administrated morphine Receives: Drug: intravenous morphine via PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
Measured: 72 hours post operatively
Fixed stimuli, variable response: measurement of reaction to fixed temperature by visual analog scale (VAS) as well as Variable stimuli, variable response (electrical stimuli)as compared to baseline.
Measured: 72 hours post operatively
patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline
Measured: 72 hours post operatively
Secondary outcomes (6)
Measurement of opioid concentration in plasma as compared to baseline
Measured: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Pupillometry as compared to baseline
Measured: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Respiratory rate as compared to baseline
Measured: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Nasal capnography at rest as compared to baseline
Measured: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Report of adverse effects' severity as compared to baseline
Measured: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Report of pain severity- at rest, cough and deep breathing as compared to baseline
Measured: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Laparotomy Pain TreatmentStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828840
- Sponsor's protocol ID
- 0080-10-HMO
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 2013
- Last updated
- 22 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.
- ClinicalTrials.gov ID
- NCT01828840
- Acronym / sponsor ID
- 0080-10-HMO
- Conditions
- Post Laparotomy Pain Treatment
- Keywords
- morphine, fentanyl, methadone, epidural, intravenous, pain, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 11 Apr 2013 (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.
The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| morphine, epidural | Active comparator | Drug: epidural morphine via PCEAEpidurally administrated morphine |
| fentanyl, epidural | Active comparator | Drug: epidural fentanyl via PCEAepidurally administrated fentanyl |
| methadone, epidural | Active comparator | Drug: epidural methadone via PCEAepidurally administrated methadone |
| morphine, intervenous | Active comparator | Drug: intravenous morphine via PCAintravenously administrated morphine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparotomy
Key exclusion criteria (10 listed)
- Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception
- Illicit drug abusers
- Chronic use of pain medication
- Inability to understand consent form
- Age < 18
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 |
|---|---|---|
| epidural morphine via PCEA | Drug | morphine, epidural |
| epidural fentanyl via PCEA | Drug | fentanyl, epidural |
| epidural methadone via PCEA | Drug | methadone, epidural |
| intravenous morphine via PCA | Drug | morphine, intervenous |
Primary outcome
Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
Time frame: 72 hours post operatively
Fixed stimuli, variable response: measurement of reaction to fixed temperature by visual analog scale (VAS) as well as Variable stimuli, variable response (electrical stimuli)as compared to baseline.
Time frame: 72 hours post operatively
patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline
Time frame: 72 hours post operatively
6 secondary outcomes
Measurement of opioid concentration in plasma as compared to baseline
Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Pupillometry as compared to baseline
Time frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Respiratory rate as compared to baseline
Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Nasal capnography at rest as compared to baseline
Time frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Report of adverse effects' severity as compared to baseline
Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Report of pain severity- at rest, cough and deep breathing as compared to baseline
Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
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 22 Mar 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural morphine via PCEA, epidural fentanyl via PCEA and epidural methadone via PCEA in people with Post Laparotomy Pain Treatment, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 10 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline (time frame: 72 hours post operatively). The study lists 3 primary outcomes in all. 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 22 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.