Acute Post-thoracotomy PainPhase 2NCT02397603
Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy
A Phase 2 study testing dexmedetomidine bupivacaine and Bupivacaine saline in people with Acute Post-thoracotomy Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Post-thoracotomy Pain
- What is being tested?
- dexmedetomidine bupivacaine and Bupivacaine saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Dec 2015
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American society of anesthesiologists physical status class ||or |||.
- Patients scheduled for elective thoracotomy.
Who cannot join
- Pneumonectomy, decortication, pleural biopsy.
- Additional chest wall resection.
- Emergency surgery.
- Central and peripheral neuropathies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy
This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.
Read the detailed description
Thoracotomy is associated with severe postoperative pain that could be reduced with an aggressive analgesic therapy in the early postoperative period. The use of thoracic paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several local anesthetic adjuvants have been reported to extend the duration of paravertebral block.
Alpha-2 agonists including dexmedetomidine appear to be the most effective in this context. The study will include an intervention group which will receive a combination of 20 ml bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20 ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter will be inserted preoperatively. Visual analogue pain score will be assessed at different intervals.
- Conditions
- Acute Post-thoracotomy Pain
- Being tested
- dexmedetomidine bupivacaine, Bupivacaine saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine bupivacaineDrug
perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block
Bupivacaine salineDrug
perineural bupivacaine saline mixture in the thoracic paravertebral catheter
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine saline group | Active comparator | This group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter Receives: Drug: Bupivacaine saline |
| Dexmedetomidine- bupivacaine group | Active comparator | This group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter. Receives: Drug: dexmedetomidine bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of first loading preoperative dose of paravertebral injectate
Time interval between initiation of the paravertebral block and the time to first rescue analgesia
Measured: One day
Secondary outcomes (10)
Duration of surgery and anesthesia
Times from start of anesthesia and surgery to the conclusion of surgical intervention
Measured: Intraoperative period, up to 3-4 hours
End tidal isoflurane
Average End-tidal isoflurane concentration required to maintain stable hemodynamics
Measured: Duration of anesthesia, up to 3-4 hours
Total intraoperative fentanyl requirements
The total dose of fentanyl required during the surgical procedure to maintain hemodynamic stability
Measured: Intraoperative period, up to 3-4 hours
Total intraoperative ephedrine and atropine requirements
The total amounts of ephidrine and atropine required for the treatment of possible reduction of arterial blood pressure or heart rate
Measured: Intraoperative period, up to 3-4 hours
Total intraoperative crystalloid requirements
The total volume of intraoperative fluids in ml required to maintain hemodynamic stability
Measured: Intraoperative period, up to 3-4 hours
Recovery time
the time interval between discontinuation of isoflurane and the patient first response to verbal commands
Measured: Immediate postoperative period, up to 2 hour
Pain intensities at rest and during coughing as assessed by 0-10 VAS score
Pain scores will be assessed using the 11-points visual analogue pain score (VAS) where 0 indicates no pain and 10 indicates the worst pain.
Measured: Over 48 hours postoperatively
Total doses of bupivacaine, dexmedetomidine, and morphine
The total doses of three medications will be recorded and compared in the intervention and control groups
Measured: 48 hours postoperatively
Number of paravertebral to-up injections
The number of to-up doses of bupivacaine required to maintain adequate postoperative analgesia over 48 hours postoperatively
Measured: 48 hours postoperatively
Side effects
Patients will be monitored for the possible reductions in arterial blood pressure and heart rate
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionDec 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 Acute Post-thoracotomy PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Mohamed Abdulatif Mohamed, Cairo University
- Investigators
- Mohamed Abdulatif, MD., Principal investigator, Professor of anesthesia, surgical intensive care and pain management cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397603
- Sponsor's protocol ID
- N-16-2015
- Status last verified
- Jan 2016
- First submitted
- 15 Mar 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.
PubMed 23161360
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT02397603
- Acronym / sponsor ID
- N-16-2015
- Conditions
- Acute Post-thoracotomy Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Mar 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.
This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.
Detailed description
Thoracotomy is associated with severe postoperative pain that could be reduced with an aggressive analgesic therapy in the early postoperative period. The use of thoracic paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several local anesthetic adjuvants have been reported to extend the duration of paravertebral block.
Alpha-2 agonists including dexmedetomidine appear to be the most effective in this context. The study will include an intervention group which will receive a combination of 20 ml bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20 ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter will be inserted preoperatively. Visual analogue pain score will be assessed at different intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine saline group | Active comparator | Drug: Bupivacaine salineThis group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter |
| Dexmedetomidine- bupivacaine group | Active comparator | Drug: dexmedetomidine bupivacaineThis group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists physical status class ||or |||.
- Patients scheduled for elective thoracotomy.
Key exclusion criteria (4 listed)
- Pneumonectomy, decortication, pleural biopsy.
- Additional chest wall resection.
- Emergency surgery.
- Central and peripheral neuropathies.
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 bupivacaineperineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block | Drug | Dexmedetomidine- bupivacaine group |
| Bupivacaine salineperineural bupivacaine saline mixture in the thoracic paravertebral catheter | Drug | bupivacaine saline group |
Primary outcome
Duration of first loading preoperative dose of paravertebral injectate
Time frame: One day
Time interval between initiation of the paravertebral block and the time to first rescue analgesia
10 secondary outcomes
Duration of surgery and anesthesia
Time frame: Intraoperative period, up to 3-4 hours
End tidal isoflurane
Time frame: Duration of anesthesia, up to 3-4 hours
Total intraoperative fentanyl requirements
Time frame: Intraoperative period, up to 3-4 hours
Total intraoperative ephedrine and atropine requirements
Time frame: Intraoperative period, up to 3-4 hours
Total intraoperative crystalloid requirements
Time frame: Intraoperative period, up to 3-4 hours
Recovery time
Time frame: Immediate postoperative period, up to 2 hour
Pain intensities at rest and during coughing as assessed by 0-10 VAS score
Time frame: Over 48 hours postoperatively
Total doses of bupivacaine, dexmedetomidine, and morphine
Time frame: 48 hours postoperatively
Number of paravertebral to-up injections
Time frame: 48 hours postoperatively
Side effects
Time frame: 48 hours postoperatively
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 2 Feb 2016.
- Results publication: PubMed 23161360Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.
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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.
Mohamed Abdulatif, MD. principal investigator
Professor of anesthesia, surgical intensive care and pain management cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexmedetomidine bupivacaine and Bupivacaine saline in people with Acute Post-thoracotomy Pain, run by Cairo 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 4 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 2 Feb 2016. 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 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.
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?
Duration of first loading preoperative dose of paravertebral injectate (time frame: One day). 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 NCT02397603, 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 2 Feb 2016.