Postoperative PainNCT01981369
Effect of Intravenous Dexmedetomidine on Analgesic Duration of Infraclavicular Block
A study testing Dexmedetomidine, Propofol and Infraclavicular block in people with Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The study will evaluate the effect of Dexmedetomidine sedation on the duration of infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All patients will receive infraclavicular block before the surgery and then they will be randomized to receive either Dexmedetomidine or Propofol… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine, Propofol and Infraclavicular block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and females of 16-80 years of age, scheduled for hand, forearm and elbow ambulatory surgery with an infraclavicular block.
- American Society of Anesthesiologist (ASA) Class I, II, III
- Ability to cooperate with study related procedures
Who cannot join
- ASA IV
- Narcotic dependent (opioid intake more than 3 months) or chronic pain conditions
- Associated significant cardiac or respiratory disease, neurological deficits
- Coexisting hematological disorder or with deranged coagulation
- Pre-existing major organ dysfunction
- Psychiatric illnesses
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- Emergency surgery
- Lack of informed consent
- Allergy to any of the drugs used in the study
- Surgical procedure duration greater than 3 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Dexmedetomidine on the Analgesic Duration of Infraclavicular Block With Ropivacaine for Upper Limb Surgery: a Prospective, Randomized, Double Blind Study
The study will evaluate the effect of Dexmedetomidine sedation on the duration of infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All patients will receive infraclavicular block before the surgery and then they will be randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory block will be evaluated in recovery room, 24 and 48 hours after the surgery.
Hypothesis:
Read more
Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
Secondary: Dexmedetomidine sedation
- Gives an adequate level of sedation during the surgical procedure
- Reduces the requirements of postoperative opioids
- Improves the quality of sleep on the night of the surgery
- Increases patients satisfaction regarding the anesthesia technique
- Dexmedetomidine sedation is safe and easy to use
- Dexmedetomidine sedation provides less respiratory depression during the procedure.
Read the detailed description
Methodology:
Study design A randomized, prospective, double blind study.
Patient groups Group 1 (control group) This group will have infraclavicular block and sedation during surgery with intravenous Propofol.
Group 2 (intervention group) This group will have infraclavicular block and sedation with intravenous Dexmedetomidine.
Recruitment and Informed consent: Recruitment will take place in the preoperative clinic or surgical day care unit.
Duration of study: We estimate that 3 patients per week will be eligible and agree to participate. One year should therefore provide adequate time for study completion.
Data analysis:
Descriptive statistics will be used to present baseline characteristics for the two groups.
T-test or Mann-Whitney U- test will be used to compare these baseline values between the two groups. Quantitative data like pain scores and narcotic consumption will be compared using repeated measures ANOVA within the groups and two tailed unpaired t-test between groups (or Mann- Whitney-U test if skewed distribution). The nonparametric data will be analyzed using Chi squared test. P less than 0.05 will be considered statistically significant. Continuous variables will be assessed for normality and will be presented as mean (SD) or median with interquartile range (IQR) as appropriate. Categorical variables will be assessed using frequency tables and Fisher's exact test. The interval between the onset of the sensory block and first analgesic request will be analyzed by Kaplan-Meier survival analysis.
Protocol: The study will be performed on patients undergoing ambulatory hand, forearm or elbow surgery. After informed consent, the patients will be randomized to a study group using a computer generated random number table and sealed envelope technique. Following this the patients will be taken to the block room for performing the infraclavicular block, using standard monitors that will include non-invasive blood pressure, electrocardiogram and pulse oximetry.
All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital. After the block, the patient will be moved to the operating room for the surgery where sedation with Dexmedetomidine or Propofol will be started as per the randomization. In order to blind the patient, the syringe and tubing will be covered with towels. The patients will be allocated to one of the two groups:
Group 1: Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery.
Group 2: Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery.
Sedation score and hemodynamic profile during the surgery will be recorded every 15 minutes. Oxygen will be provided through facial mask. Total dose of narcotic used will be recorded.
After the surgical procedure, patients will be moved to the Post Anesthetic Care Unit (PACU), where an independent blinded observer not involved in the performance of the block or intraoperative care of the patient, will follow up the patients in the postoperative period.
The patients will be assessed for the site and severity of pain at rest at the arrival in the PACU. Pain score will be the Numerical Rating Score (NRS) on a scale of 0 to 10 where 0 is no pain and 10 the worst pain ever experienced. Data regarding duration of surgery and the duration of stay in PACU will also be collected from the nursing records. Opioids requirement in PACU will also be collected from these records. Complications, if any will be noted.
The patients will be assessed for pain at the surgical site at the time of discharge from PACU. They will also be given a diary to take home. Patient will be educated regarding the NRS and asked to record in the diary after discharge from the PACU until 20:00 hours. They will also be asked to record when they require first analgesic dose, the time of return of sensation in dorsal area of the hand/finger and also the time when they are able to extend the wrist.
Patients will be instructed to take their oral rescue analgesic once the pain is score >5/10.
Patients will be contacted by phone 24 hours and 48 hours after their time of arrival in PACU (time 0). They will be reminded regarding entry in the diary. They will also be asked about quality of sleep.
Patient satisfaction will be documented at 24 and 48 hours on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied.
The total participation time for the patients is for 2 days.
Sample size estimation The sample size is calculated for the primary outcome measure, which is the duration of the sensory block.
The duration of sensory infraclavicular block when the local anesthetic is Ropivacaine is 402 (± 183) minutes (Abdallah et al. Anesthesiology 2016; 124:683-95). With an equivalence limit (d) of 180 minutes and the calculation of the sample size with the following formula:
n = f(α, β) × 2 × σ2 / d2 (non-inferiority) and n = f(α/2, β) × 2 × σ2 / (μ1 - μ2)2 (superiority) This showed 27 patients per group (non-inferiority) and 32 patients per group (superiority), were required to ensure adequate sample size with an α of 2.5% and 95% power. We plan to have 50 patients per group, considering a high non-compliance rate.
Randomization: This will be performed using a computer generated randomization and closed envelope system. Patients will be randomized on the day of the surgical procedure. This study will be double blind because patients, anesthesiologist performing the infraclavicular block and the evaluator in the postoperative setting will not know the allocation group. The anesthesiologist providing the sedation in the Operating Room will prepare the sedative agents (Propofol and/or Dexmedetomidine) and will cover the infusions with drapes (Propofol is a white solution, the only way to hide it is to cover it with drapes). This person will not be blinded but will also not be part of the study.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine, Propofol, Infraclavicular block
- Keywords
- Dexmedetomidine sedation, Regional Anesthesia, Infraclavicular block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Intravenous sedation with dexmedetomidine
PropofolDrug
Intravenous sedation with propofol
Infraclavicular blockProcedure or surgery
All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Propofol sedation. | Active comparator | This group will have infraclavicular block and sedation during surgery with intravenous Propofol. Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery. Receives: Drug: Propofol; Procedure: Infraclavicular block |
| Dexmedetomidine sedation. | Experimental | This group will have infraclavicular block and sedation with intravenous Dexmedetomidine. Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery. Receives: Drug: Dexmedetomidine; Procedure: Infraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
In the data collection form will be record the time of performance of the infraclavicular block. The patients will have a diary where they will record the time of the day when day have the first analgesic request because of pain in the surgical site.
Measured: The primary outcome will be the duration of the sensory infraclavicular block in minutes, from the moment that the block is perfomed and the moment of first analgesic request.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2016
- Study completionDec 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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, MD, FRCPC, Principal investigator, Lawson Health Research Institute & Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981369
- Sponsor's protocol ID
- 104572
- Status last verified
- May 2019
- First submitted
- 5 Nov 2013
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexmedetomidine on the Analgesic Duration of Infraclavicular Block With Ropivacaine for Upper Limb Surgery: a Prospective, Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT01981369
- Acronym / sponsor ID
- 104572
- Conditions
- Postoperative Pain
- Keywords
- Dexmedetomidine sedation, Regional Anesthesia, Infraclavicular block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2013 (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 study will evaluate the effect of Dexmedetomidine sedation on the duration of infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All patients will receive infraclavicular block before the surgery and then they will be randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory block will be evaluated in recovery room, 24 and 48 hours after the surgery.
Hypothesis:
Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
Secondary: Dexmedetomidine sedation
- Gives an adequate level of sedation during the surgical procedure
- Reduces the requirements of postoperative opioids
- Improves the quality of sleep on the night of the surgery
- Increases patients satisfaction regarding the anesthesia technique
- Dexmedetomidine sedation is safe and easy to use
- Dexmedetomidine sedation provides less respiratory depression during the procedure.
Detailed description
Methodology:
Study design A randomized, prospective, double blind study.
Patient groups Group 1 (control group) This group will have infraclavicular block and sedation during surgery with intravenous Propofol.
Group 2 (intervention group) This group will have infraclavicular block and sedation with intravenous Dexmedetomidine.
Recruitment and Informed consent: Recruitment will take place in the preoperative clinic or surgical day care unit.
Duration of study: We estimate that 3 patients per week will be eligible and agree to participate. One year should therefore provide adequate time for study completion.
Data analysis:
Descriptive statistics will be used to present baseline characteristics for the two groups.
T-test or Mann-Whitney U- test will be used to compare these baseline values between the two groups. Quantitative data like pain scores and narcotic consumption will be compared using repeated measures ANOVA within the groups and two tailed unpaired t-test between groups (or Mann- Whitney-U test if skewed distribution). The nonparametric data will be analyzed using Chi squared test. P less than 0.05 will be considered statistically significant. Continuous variables will be assessed for normality and will be presented as mean (SD) or median with interquartile range (IQR) as appropriate. Categorical variables will be assessed using frequency tables and Fisher's exact test. The interval between the onset of the sensory block and first analgesic request will be analyzed by Kaplan-Meier survival analysis.
Protocol: The study will be performed on patients undergoing ambulatory hand, forearm or elbow surgery. After informed consent, the patients will be randomized to a study group using a computer generated random number table and sealed envelope technique. Following this the patients will be taken to the block room for performing the infraclavicular block, using standard monitors that will include non-invasive blood pressure, electrocardiogram and pulse oximetry.
All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital. After the block, the patient will be moved to the operating room for the surgery where sedation with Dexmedetomidine or Propofol will be started as per the randomization. In order to blind the patient, the syringe and tubing will be covered with towels. The patients will be allocated to one of the two groups:
Group 1: Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery.
Group 2: Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery.
Sedation score and hemodynamic profile during the surgery will be recorded every 15 minutes. Oxygen will be provided through facial mask. Total dose of narcotic used will be recorded.
After the surgical procedure, patients will be moved to the Post Anesthetic Care Unit (PACU), where an independent blinded observer not involved in the performance of the block or intraoperative care of the patient, will follow up the patients in the postoperative period.
The patients will be assessed for the site and severity of pain at rest at the arrival in the PACU. Pain score will be the Numerical Rating Score (NRS) on a scale of 0 to 10 where 0 is no pain and 10 the worst pain ever experienced. Data regarding duration of surgery and the duration of stay in PACU will also be collected from the nursing records. Opioids requirement in PACU will also be collected from these records. Complications, if any will be noted.
The patients will be assessed for pain at the surgical site at the time of discharge from PACU. They will also be given a diary to take home. Patient will be educated regarding the NRS and asked to record in the diary after discharge from the PACU until 20:00 hours. They will also be asked to record when they require first analgesic dose, the time of return of sensation in dorsal area of the hand/finger and also the time when they are able to extend the wrist.
Patients will be instructed to take their oral rescue analgesic once the pain is score >5/10.
Patients will be contacted by phone 24 hours and 48 hours after their time of arrival in PACU (time 0). They will be reminded regarding entry in the diary. They will also be asked about quality of sleep.
Patient satisfaction will be documented at 24 and 48 hours on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied.
The total participation time for the patients is for 2 days.
Sample size estimation The sample size is calculated for the primary outcome measure, which is the duration of the sensory block.
The duration of sensory infraclavicular block when the local anesthetic is Ropivacaine is 402 (± 183) minutes (Abdallah et al. Anesthesiology 2016; 124:683-95). With an equivalence limit (d) of 180 minutes and the calculation of the sample size with the following formula:
n = f(α, β) × 2 × σ2 / d2 (non-inferiority) and n = f(α/2, β) × 2 × σ2 / (μ1 - μ2)2 (superiority) This showed 27 patients per group (non-inferiority) and 32 patients per group (superiority), were required to ensure adequate sample size with an α of 2.5% and 95% power. We plan to have 50 patients per group, considering a high non-compliance rate.
Randomization: This will be performed using a computer generated randomization and closed envelope system. Patients will be randomized on the day of the surgical procedure. This study will be double blind because patients, anesthesiologist performing the infraclavicular block and the evaluator in the postoperative setting will not know the allocation group. The anesthesiologist providing the sedation in the Operating Room will prepare the sedative agents (Propofol and/or Dexmedetomidine) and will cover the infusions with drapes (Propofol is a white solution, the only way to hide it is to cover it with drapes). This person will not be blinded but will also not be part of the study.
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 |
|---|---|---|
| Propofol sedation. | Active comparator | Drug: Propofol, Procedure: Infraclavicular blockThis group will have infraclavicular block and sedation during surgery with intravenous Propofol. Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery. |
| Dexmedetomidine sedation. | Experimental | Drug: Dexmedetomidine, Procedure: Infraclavicular blockThis group will have infraclavicular block and sedation with intravenous Dexmedetomidine. Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and females of 16-80 years of age, scheduled for hand, forearm and elbow ambulatory surgery with an infraclavicular block.
- American Society of Anesthesiologist (ASA) Class I, II, III
- Ability to cooperate with study related procedures
Key exclusion criteria (10 listed)
- ASA IV
- Narcotic dependent (opioid intake more than 3 months) or chronic pain conditions
- Associated significant cardiac or respiratory disease, neurological deficits
- Coexisting hematological disorder or with deranged coagulation
- Pre-existing major organ dysfunction
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexIntravenous sedation with dexmedetomidine | Drug | Dexmedetomidine sedation. |
| PropofolIntravenous sedation with propofol | Drug | Propofol sedation. |
| Infraclavicular blockAll patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital. | Procedure or surgery | Dexmedetomidine sedation., Propofol sedation. |
Primary outcome
The duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
Time frame: The primary outcome will be the duration of the sensory infraclavicular block in minutes, from the moment that the block is perfomed and the moment of first analgesic request.
In the data collection form will be record the time of performance of the infraclavicular block. The patients will have a diary where they will record the time of the day when day have the first analgesic request because of pain in the surgical site.
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 29 May 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.
Shalini Dhir, MD, FRCPC principal investigator
Lawson Health Research Institute & Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Propofol and Infraclavicular block in people with Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 10 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 29 May 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 Canada. 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.
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?
The duration of sensory infraclavicular block in patients scheduled for upper limb surgery. (time frame: The primary outcome will be the duration of the sensory infraclavicular block in minutes, from the moment that the block is perfomed and the moment of first analgesic request.). 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 29 May 2019.