HyperalgesiaPhase 4NCT03225690
Prevention of Hyperalgesia With Epidural Morphine
A Phase 4 study testing Morphine and Serum physiologic in people with Hyperalgesia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the all patients. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- Morphine and Serum physiologic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2017to 1 Dec 2018
- Phase
- Phase 4
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- Patients who undergoing major abdominal surgery
Who cannot join
- ASA IV and up
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çukurova University Balcalı Hospital
Adana, 01380
Çukurova University B Hospital
About this study
Official title: Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia
American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.
Read the detailed description
This randomized, double blind, controlled study will perform after obtaining informed consent and ethics approval. American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups with computerized randomization programme. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and N2O-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.
- Conditions
- Hyperalgesia
- Being tested
- Morphine, Serum physiologic
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Group I-II
Prevention of remifentanil induced hyperalgesia
Serum physiologicDrug
Also called Group III
For placebo, serum physiologic will use
| Study group | Role | What they receive |
|---|---|---|
| serum physiologic | Placebo comparator | 2 ml serum physiologic will apply via epidural catheter before surgical incision. Receives: Drug: Serum physiologic |
| Preemptive Morphine | Active comparator | 1 mg morphine will apply via epidural catheter before surgical incision. Receives: Drug: Morphine |
| Morphine | Active comparator | 1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic requirement
Calculation of epidural bupivacain consumption
Measured: Till the postoperative 24th hour.
Secondary outcomes (1)
Algometer values
Postoperative pain will detect with algometer
Measured: Till the postoperative 24th hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start19 Jul 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- Ebru Biricik, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225690
- Sponsor's protocol ID
- Hyperalgesia
- Status last verified
- Nov 2017
- First submitted
- 2 Jun 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia
- ClinicalTrials.gov ID
- NCT03225690
- Acronym / sponsor ID
- Hyperalgesia
- Conditions
- Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- 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.
American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.
Detailed description
This randomized, double blind, controlled study will perform after obtaining informed consent and ethics approval. American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups with computerized randomization programme. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and N2O-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| serum physiologic | Placebo comparator | Drug: Serum physiologic2 ml serum physiologic will apply via epidural catheter before surgical incision. |
| Preemptive Morphine | Active comparator | Drug: Morphine1 mg morphine will apply via epidural catheter before surgical incision. |
| Morphine | Active comparator | Drug: Morphine1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III patients
- Patients who undergoing major abdominal surgery
Key exclusion criteria (2 listed)
- ASA IV and up
- Coagulopathy
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 |
|---|---|---|
| MorphineAlso: Group I-IIPrevention of remifentanil induced hyperalgesia | Drug | Morphine, Preemptive Morphine |
| Serum physiologicAlso: Group IIIFor placebo, serum physiologic will use | Drug | serum physiologic |
Primary outcome
Postoperative analgesic requirement
Time frame: Till the postoperative 24th hour.
Calculation of epidural bupivacain consumption
1 secondary outcome
Algometer values
Time frame: Till the postoperative 24th hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Ebru Biricik study chair
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine and Serum physiologic in people with Hyperalgesia, run by Cukurova University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Mar 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru Biricik (5052420223, ebrubiricik01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic requirement (time frame: Till the postoperative 24th hour.). 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 Mar 2018.