Postoperative AnalgesiaPhase 2/3NCT03060070
Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block
A Phase 2/3 study testing Ketamine and dexmedetomidine in people with Postoperative Analgesia and Lower Abdominal Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Analgesia, Lower Abdominal Cancer
- What is being tested?
- Ketamine and dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2017to 1 Jul 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study
Who cannot join
- Coagulopathies
- ASA III or IV, patient refusal, sensitivity to the used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Analgesic Effect of Ketamine Versus Dexmedetomidine Added to Local Anesthetic in TAP Block for Lower Abdominal Cancer Surgery
Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.
- Conditions
- Postoperative Analgesia, Lower Abdominal Cancer
- Being tested
- Ketamine, dexmedetomidine, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
dexmedetomidineDrug
dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
control groupDrug
20ml of 0.25% bupivacaine will be injected in each side of the TAP block
| Study group | Role | What they receive |
|---|---|---|
| control group, | Placebo comparator | saline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery Receives: Drug: Ketamine; Drug: dexmedetomidine |
| ketamine group, | Active comparator | ketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery Receives: Drug: dexmedetomidine; Drug: control group |
| dexmedetomidine group | Active comparator | dexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery Receives: Drug: Ketamine; Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative rescue morphine consumption
postoperative rescue morphine consumption
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 posted23 Feb 2017
- Study start10 Mar 2017
- Primary completion25 Jun 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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
- 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
- Collaborators
- South Egypt Cancer Institute
- Responsible party
- Principal investigator, Ahmed H Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060070
- Sponsor's protocol ID
- 321
- Status last verified
- Jul 2017
- First submitted
- 17 Feb 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect of Ketamine Versus Dexmedetomidine Added to Local Anesthetic in TAP Block for Lower Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03060070
- Acronym / sponsor ID
- 321
- Conditions
- Postoperative Analgesia, Lower Abdominal Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- South Egypt Cancer Institute
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 23 Feb 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.
Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group, | Placebo comparator | Drug: Ketamine, Drug: dexmedetomidinesaline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery |
| ketamine group, | Active comparator | Drug: dexmedetomidine, Drug: control groupketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery |
| dexmedetomidine group | Active comparator | Drug: Ketamine, Drug: control groupdexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study
Key exclusion criteria (2 listed)
- Coagulopathies
- ASA III or IV, patient refusal, sensitivity to the used drugs
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 |
|---|---|---|
| KetamineKetamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block | Drug | control group,, dexmedetomidine group |
| dexmedetomidinedexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block | Drug | control group,, ketamine group, |
| control group20ml of 0.25% bupivacaine will be injected in each side of the TAP block | Drug | dexmedetomidine group, ketamine group, |
Primary outcome
postoperative rescue morphine consumption
Time frame: 24 hours postoperative
postoperative rescue morphine consumption
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 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine and dexmedetomidine in people with Postoperative Analgesia and Lower Abdominal Cancer, run by Assiut University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 5 Jul 2017. 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 Egypt. 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 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?
postoperative rescue morphine consumption (time frame: 24 hours postoperative). 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 Jul 2017.