Postoperative PainPhase 2/3ITMandDEXNCT02435537
Combined Intrathecal Morphine and Dexmedetomidine Analgesia
A Phase 2/3 study testing Dexmedetomidine (Precedex), Bupivacaine and Morphine in people with Postoperative Pain, run by Assiut University.
Trial summary
The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine (Precedex), Bupivacaine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Mar 2015
- Phase
- Phase 2/3
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)
Who cannot join
- known allergy to study drugs
- Significant cardiac, respiratory, renal or hepatic disease.
- 2nd or 3rd degree heart block.
- Coagulation disorders.
- Low back pain or other back problems.
- Drug or alcohol abuse.
- BMI>30kg\m2.
- Psychiatric illnesses that would interfere with perception and assessment of pain.
About this study
Official title: Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery
The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.
Read the detailed description
Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine (Precedex), Bupivacaine, Morphine
- Keywords
- analgesia, intrathecal, opioids, morphine, dexmedetomidine
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine (Precedex)Drug
Also called Precedex
intrathecal administration
BupivacaineDrug
Also called Buvicaine
intrathecal 10 mg bupivacaine
MorphineDrug
Also called morphine sulphate
intrathecal 0.5mg morphine
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Bupivacaine | Active comparator | intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9% Receives: Drug: Bupivacaine |
| Intrathecal Morphine | Active comparator | intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume Receives: Drug: Bupivacaine; Drug: Morphine |
| Intrathecal Morphine-Dex | Active comparator | intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume . Receives: Drug: Dexmedetomidine (Precedex); Drug: Bupivacaine; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dose of intravenous PCA morphine consumption in the first 48 h postoperative
Calculating the cumulative intravenous PCA morphine dose
Measured: 48 hours
Secondary outcomes (5)
Noninvasive blood pressure
non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
Measured: 48 hours
Heart rate
non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative
Measured: 48 hours
peripheral arterial oxygen saturation
assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative
Measured: 48 hours
postoperative VAS scores
assessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
Measured: 48 hours
time to first request for analgesia
measuring the time in hours of first request for intravenous PCA morphine
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Fares, Assiut University
- Investigators
- Saher AB Mohamed, MD, Study director, Assisstant professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, EgyptHala s Abdel-Ghaffar, MD, Study director, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435537
- Sponsor's protocol ID
- IORG0006563/reference. no. 64
- Acronym
- ITMandDEX
- Status last verified
- May 2015
- First submitted
- 26 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abdel-Ghaffar HS, Mohamed SA, Fares KM. Combined Intrathecal Morphine and Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Major Abdominal Cancer Surgery. Pain Med. 2016 Nov;17(11):2109-2118. doi: 10.1093/pm/pnw031. Epub 2016 Mar 21.
PubMed 27002003
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02435537
- Acronym / sponsor ID
- ITMandDEX / IORG0006563/reference. no. 64
- Conditions
- Postoperative Pain
- Keywords
- analgesia, intrathecal, opioids, morphine, dexmedetomidine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 May 2015 (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 investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.
Detailed description
Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Bupivacaine | Active comparator | Drug: Bupivacaineintrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9% |
| Intrathecal Morphine | Active comparator | Drug: Bupivacaine, Drug: Morphineintrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume |
| Intrathecal Morphine-Dex | Active comparator | Drug: Dexmedetomidine (Precedex), Drug: Bupivacaine, Drug: Morphineintrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume . |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)
Key exclusion criteria (8 listed)
- known allergy to study drugs
- Significant cardiac, respiratory, renal or hepatic disease.
- 2nd or 3rd degree heart block.
- Coagulation disorders.
- Low back pain or other back problems.
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 |
|---|---|---|
| Dexmedetomidine (Precedex)Also: Precedexintrathecal administration | Drug | Intrathecal Morphine-Dex |
| BupivacaineAlso: Buvicaineintrathecal 10 mg bupivacaine | Drug | Intrathecal Bupivacaine, Intrathecal Morphine, Intrathecal Morphine-Dex |
| MorphineAlso: morphine sulphateintrathecal 0.5mg morphine | Drug | Intrathecal Morphine, Intrathecal Morphine-Dex |
Primary outcome
total dose of intravenous PCA morphine consumption in the first 48 h postoperative
Time frame: 48 hours
Calculating the cumulative intravenous PCA morphine dose
5 secondary outcomes
Noninvasive blood pressure
Time frame: 48 hours
Heart rate
Time frame: 48 hours
peripheral arterial oxygen saturation
Time frame: 48 hours
postoperative VAS scores
Time frame: 48 hours
time to first request for analgesia
Time frame: 48hours
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 6 May 2015.
- Derived from this study: PubMed 27002003Abdel-Ghaffar HS, Mohamed SA, Fares KM. Combined Intrathecal Morphine and Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Major Abdominal Cancer Surgery. Pain Med. 2016 Nov;17(11):2109-2118. doi: 10.1093/pm/pnw031. Epub 2016 Mar 21.
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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.
Saher AB Mohamed, MD study director
Assisstant professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt
Hala s Abdel-Ghaffar, MD study director
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine (Precedex), Bupivacaine and Morphine in people with Postoperative Pain, run by Assiut 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 1 inclusion and 8 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 6 May 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
total dose of intravenous PCA morphine consumption in the first 48 h postoperative (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435537, which also lists 1 linked publication.
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 6 May 2015.