Acute PainPhase 2/3NCT03063671
Dexmedetomidine,Ketamine and Their Combination to Bupivicaine on Thoracic Epidural Analgesia
A Phase 2/3 study testing Ketamine, bupivacine,dexmedetomidine in people with Acute Pain, run by Assiut University at 1 site in Egypt.
Trial summary
This study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- Ketamine, bupivacine,dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Apr 2018
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for modified radical mastectomy.
- ASA Physical status I, II and III.
Who cannot join
- Patients' refusal.
- Uncooperative patients \& severe psychiatric illness (cannot evaluate their own pain intensity using visual analogue scale (VAS).
- Patients with history of drug allergy.
- severe renal or liver impairment, unstable ischemic heart disease
- Any contraindications to epidural analgesia (coagulopathy, recent -less than 1 week-treatment with thrombolytic or potent antiplatelet drugs as clopidogrel, and local infection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Dexmedetomidine, Ketamine and Their Combination to Bupivicaine in Thoracic Epidural Analgesia on Post-mastectomy Pain
This study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery.
Read the detailed description
Breast cancer is the most common cancer diagnosed in Egyptian women. Many modalities are used in the treatment of breast cancer including chemotherapy, radiotherapy or surgical intervention. Nowadays, surgical intervention is more conservative.Modified radical mastectomy (MRM) is the standard surgical procedure of choice in these patients. MRM is usually performed under general anesthesia, almost always combining intravenous and inhalational agents.The drawback of general anesthesia includes inadequate pain control due to lack of analgesia, high incidence of nausea and vomiting, stress of anesthesia and surgery, and increasing the length of hospital stay.Post mastectomy pain is a pain which occur following breast cancer procedures, particularly those operations that remove tissues in upper outer quadrant of breast and/or axilla. This pain can be severe enough to cause long term disabilities and interfere with sleep, performance of daily activities. Also, it can seriously affect the patient mood, and social functions.
Thoracic epidural analgesia (TEA) faces growing interest as adjuvant anesthetic and post-operative analgesic regimen. the use of adjuvant drug with local anesthetic is essential as it prolongs the duration of action, gives better success rate and increases patient satisfaction.
Ketamine, an N-methyl-D-aspartate (NMDA) antagonist, not only abolishes peripheral afferent noxious stimulation, but it can also prevent the central sensitization of nociceptors. When added to epidural local anesthetics, ketamine appears to have adjuvant effects. Dexmedetomedine is a selective, α2-adrenoceptor agonist with analgesic potency, sedative properties, and minimal respiratory depression when used as an adjuvant to regional anesthesia.
- Conditions
- Acute Pain
- Being tested
- Ketamine, bupivacine,dexmedetomidine
- Keywords
- postmastectomy pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine, bupivacine,dexmedetomidineDrug
thoracic epidural catheter insertion at T4-5
| Study group | Role | What they receive |
|---|---|---|
| bupivacine group | Active comparator | preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% as one shot 15 minutes before general anesthesia postoperative analgesia done by infusion of bupivacaine 0.125% (5ml/hour through thoracic epidural catheter for 12 hours). Receives: Drug: Ketamine, bupivacine,dexmedetomidine |
| ketamine group | Active comparator | preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus ketamine in a dose 0.5 mg/kg 15 minutes before general anesthesia postoperative analgesia will be preformed by infusion of mixture of (bupivacaine 0.125% plus ketamine 0.5 mg/ml ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours Receives: Drug: Ketamine, bupivacine,dexmedetomidine |
| dexmedetomidine group | Active comparator | preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus dexmedetomidine in a dose 1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours. Receives: Drug: Ketamine, bupivacine,dexmedetomidine |
| ketamine-dexmedetomidine group | Active comparator | preoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus both ketamine in a dose 0.3 mg/kg and dexmedetomidine in a dose 0.1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml and and ketamine 0.5 mg/ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours. Receives: Drug: Ketamine, bupivacine,dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dose of intravenous morphine consumption in the first 48 hours post operatively
total dose of intravenous morphine comsumption
Measured: 48 hours postoperative
Secondary outcomes (4)
Visual analogue scale
Visual analogue scale will be assessed at rest and on movement (abduction of the ipsi-lateral arm).
Measured: 0, 2,4,6,8,18,36,48 hours
MAP
mean arterial blood pressure
Measured: 0,30,60,120,150 minutes
HR
heart rate
Measured: 0,30,60,120,150 minutes
sedation score
sedation sore using sedation scale where; 0 = aware - 1 = drowsy - 2 = asleep/easily respond to verbal command - 3 = asleep/difficulty responding to verbal command -4 = asleep/no respond to verbal command
Measured: 0, 2,4,6,8,18,36,48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startJan 2017
- Primary completionJul 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063671
- Sponsor's protocol ID
- 110
- Status last verified
- Jun 2019
- First submitted
- 21 Feb 2017
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexmedetomidine, Ketamine and Their Combination to Bupivicaine in Thoracic Epidural Analgesia on Post-mastectomy Pain
- ClinicalTrials.gov ID
- NCT03063671
- Acronym / sponsor ID
- 110
- Conditions
- Acute Pain
- Keywords
- postmastectomy pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 24 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.
This study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery.
Detailed description
Breast cancer is the most common cancer diagnosed in Egyptian women. Many modalities are used in the treatment of breast cancer including chemotherapy, radiotherapy or surgical intervention. Nowadays, surgical intervention is more conservative.Modified radical mastectomy (MRM) is the standard surgical procedure of choice in these patients. MRM is usually performed under general anesthesia, almost always combining intravenous and inhalational agents.The drawback of general anesthesia includes inadequate pain control due to lack of analgesia, high incidence of nausea and vomiting, stress of anesthesia and surgery, and increasing the length of hospital stay.Post mastectomy pain is a pain which occur following breast cancer procedures, particularly those operations that remove tissues in upper outer quadrant of breast and/or axilla. This pain can be severe enough to cause long term disabilities and interfere with sleep, performance of daily activities. Also, it can seriously affect the patient mood, and social functions.
Thoracic epidural analgesia (TEA) faces growing interest as adjuvant anesthetic and post-operative analgesic regimen. the use of adjuvant drug with local anesthetic is essential as it prolongs the duration of action, gives better success rate and increases patient satisfaction.
Ketamine, an N-methyl-D-aspartate (NMDA) antagonist, not only abolishes peripheral afferent noxious stimulation, but it can also prevent the central sensitization of nociceptors. When added to epidural local anesthetics, ketamine appears to have adjuvant effects. Dexmedetomedine is a selective, α2-adrenoceptor agonist with analgesic potency, sedative properties, and minimal respiratory depression when used as an adjuvant to regional anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bupivacine group | Active comparator | Drug: Ketamine, bupivacine,dexmedetomidinepreoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% as one shot 15 minutes before general anesthesia postoperative analgesia done by infusion of bupivacaine 0.125% (5ml/hour through thoracic epidural catheter for 12 hours). |
| ketamine group | Active comparator | Drug: Ketamine, bupivacine,dexmedetomidinepreoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus ketamine in a dose 0.5 mg/kg 15 minutes before general anesthesia postoperative analgesia will be preformed by infusion of mixture of (bupivacaine 0.125% plus ketamine 0.5 mg/ml ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours |
| dexmedetomidine group | Active comparator | Drug: Ketamine, bupivacine,dexmedetomidinepreoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus dexmedetomidine in a dose 1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours. |
| ketamine-dexmedetomidine group | Active comparator | Drug: Ketamine, bupivacine,dexmedetomidinepreoperative insertion of thoracic epidural at T4-5 and adminstration of 12 ml bupivacine 0.125% plus both ketamine in a dose 0.3 mg/kg and dexmedetomidine in a dose 0.1 ug/kg 15 minutes before general anesthesia Postoperative analgesia will be performed using infusion of mixture of (bupivacaine 0.125% plus dexmedetomedine 2μg/ ml and and ketamine 0.5 mg/ml) in a rate of 5ml/hour through thoracic epidural catheter for 12 hours. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for modified radical mastectomy.
- ASA Physical status I, II and III.
Key exclusion criteria (5 listed)
- Patients' refusal.
- Uncooperative patients \& severe psychiatric illness (cannot evaluate their own pain intensity using visual analogue scale (VAS).
- Patients with history of drug allergy.
- severe renal or liver impairment, unstable ischemic heart disease
- Any contraindications to epidural analgesia (coagulopathy, recent -less than 1 week-treatment with thrombolytic or potent antiplatelet drugs as clopidogrel, and local infection).
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 |
|---|---|---|
| Ketamine, bupivacine,dexmedetomidinethoracic epidural catheter insertion at T4-5 | Drug | bupivacine group, dexmedetomidine group, ketamine group, ketamine-dexmedetomidine group |
Primary outcome
total dose of intravenous morphine consumption in the first 48 hours post operatively
Time frame: 48 hours postoperative
total dose of intravenous morphine comsumption
4 secondary outcomes
Visual analogue scale
Time frame: 0, 2,4,6,8,18,36,48 hours
MAP
Time frame: 0,30,60,120,150 minutes
HR
Time frame: 0,30,60,120,150 minutes
sedation score
Time frame: 0, 2,4,6,8,18,36,48 hours
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 28 Jun 2019.
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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, bupivacine,dexmedetomidine in people with Acute Pain, 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 2 inclusion and 5 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 28 Jun 2019. 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. 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 morphine consumption in the first 48 hours post operatively (time frame: 48 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 28 Jun 2019.