Postoperative PainPhase 2/3NCT02726828
intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
A Phase 2/3 study testing intrathecal morphine, intrathecal ketamine and intrathecal morphine + ketamine in people with Postoperative Pain, run by Assiut University.
Trial summary
this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- intrathecal morphine, intrathecal ketamine and intrathecal morphine + ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Apr 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesia (ASA) I-III patients.
- aged 30-50 years.
- scheduled for major abdominal cancer surgery.
Who cannot join
- Patients with a known allergy to the study drugs.
- significant cardiac, respiratory, renal or hepatic disease.
- coagulation disorders.
- infection at or near the site of intrathecal injection.
- drug or alcohol abuse.
- BMI > 30 kg/m2.
- psychiatric illnesses that may interfere with perception and assessment of pain.
About this study
Official title: Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery
this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.
- Conditions
- Postoperative Pain
- Being tested
- intrathecal morphine, intrathecal ketamine, intrathecal morphine + ketamine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal morphineDrug
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
intrathecal ketamineDrug
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
intrathecal morphine + ketamineDrug
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.
| Study group | Role | What they receive |
|---|---|---|
| group I: morphine group | Active comparator | patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally. Receives: Drug: intrathecal morphine |
| group II: ketamine group | Active comparator | patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally. Receives: Drug: intrathecal ketamine |
| group III: morphine + ketamine group | Active comparator | patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally. Receives: Drug: intrathecal morphine + ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) scores
postoperative pain measured by this score.
Measured: 24 hours postoperative
time to first analgesic request
the time passed till the first request of rescue analgesia by the patients
Measured: 24 hours postoperative
total analgesic consumption
the total amount of rescue analgesic drug used allover follow up period
Measured: 24 hours postoperative
Secondary outcomes (1)
side effects
the type and rate of incidence of side effects during the follow up period
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionApr 2016
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 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726828
- Sponsor's protocol ID
- 165
- Status last verified
- Jan 2017
- First submitted
- 30 Mar 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT02726828
- Acronym / sponsor ID
- 165
- Conditions
- Postoperative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 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.
this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I: morphine group | Active comparator | Drug: intrathecal morphinepatients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally. |
| group II: ketamine group | Active comparator | Drug: intrathecal ketaminepatients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally. |
| group III: morphine + ketamine group | Active comparator | Drug: intrathecal morphine + ketaminepatients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesia (ASA) I-III patients.
- aged 30-50 years.
- scheduled for major abdominal cancer surgery.
Key exclusion criteria (7 listed)
- Patients with a known allergy to the study drugs.
- significant cardiac, respiratory, renal or hepatic disease.
- coagulation disorders.
- infection at or near the site of intrathecal injection.
- drug or alcohol abuse.
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 |
|---|---|---|
| intrathecal morphinepatients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume. | Drug | group I: morphine group |
| intrathecal ketaminepatients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume. | Drug | group II: ketamine group |
| intrathecal morphine + ketaminepatients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume. | Drug | group III: morphine + ketamine group |
Primary outcome
Visual Analogue Scale (VAS) scores
Time frame: 24 hours postoperative
postoperative pain measured by this score.
time to first analgesic request
Time frame: 24 hours postoperative
the time passed till the first request of rescue analgesia by the patients
total analgesic consumption
Time frame: 24 hours postoperative
the total amount of rescue analgesic drug used allover follow up period
1 secondary outcome
side effects
Time frame: 24 hours postoperative
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 26 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 2/3 study testing intrathecal morphine, intrathecal ketamine and intrathecal morphine + ketamine 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 3 inclusion and 7 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 26 Jan 2017. 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?
Visual Analogue Scale (VAS) scores (time frame: 24 hours postoperative). 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 26 Jan 2017.