Postoperative PainPhase 4NCT03057015
Addition of Clonidine to Ropivacaine in Adductor Canal Block
A Phase 4 study testing Clonidine, Ropivacaine and Dexamethasone in people with Postoperative Pain, run by University of Vermont at 1 site in United States.
Trial summary
Total knee arthroplasty (knee replacement) is a common orthopedic procedure for osteoarthritis. This procedure is performed either under general anesthesia or spinal anesthesia; after the procedure in the recovery room, these patients undergo adductor canal block, which is a nerve block to provide 8-14 hours of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Clonidine, Ropivacaine and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 28 Feb 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 18 and older
- ASA physical status classification system I, II and III (healthy patient or patient with mild to moderate systemic disease)
- Patient coming in for elective total knee arthroplasty under general or neuraxial anesthesia and postoperative adductor canal block
- Patients staying for at least 24 hrs post operatively
- Patients who provide informed consent
- Patients presenting for surgery >1 hour in length and <6 hours.
Who cannot join
- History of recent common colds, upper respiratory infections or immune deficiencies
- Patients allergic to clonidine
- Pregnant women (all women of childbearing age undergo pregnancy testing prior to anesthesia as per UVMMC peri-operative protocol)
- Patients who are already on chronic clonidine therapy for management of blood pressure
- Patients on chronic opioid therapy defined as more than 10 mg of oxycodone per day (or equivalent doses of other opioid analgesics)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Borzoo Farhang, DO, 802-881-9927, borzoo.farhang@uvmhealth.org
Borzoo Farhang, DO
About this study
Official title: Addition of Clonidine to Ropivacaine in Adductor Canal Block for Postoperative Pain Relief in Total Knee Arthroplasty: A Prospective Randomized Double Blind Placebo Controlled Trial
Total knee arthroplasty (knee replacement) is a common orthopedic procedure for osteoarthritis. This procedure is performed either under general anesthesia or spinal anesthesia; after the procedure in the recovery room, these patients undergo adductor canal block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve the quality of pain control as well as the duration of pain relief. The primary local anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are epinephrine and dexamethasone.
There is conflicting data available in the literature regarding efficacy of addition of clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data assessing the efficacy of this medication in adductor canal blocks.
Read more
Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be given to the acute pain service staff performing the nerve block. This will be mixed with local anesthetic solution and injected in the adductor canal under ultrasound guidance.
The primary outcome measure will be the duration of analgesia, which will be assessed as the time interval between placement of adductor canal block to the first request of opioid analgesic by patients (which will be obtained from hospital electronic medical records). Secondary outcomes will include:
- Duration of sensory block, which will be assessed as the time interval between injection of local anesthetic and report of postoperative pain of 3 or more on an 11 point scale (0=no pain; 10= worst pain imaginable) by the patient (this will be assessed every 4 hours).
- Duration of motor block, which will be assessed as the time interval between the onset of motor block to complete recovery of motor block by assessing straight leg raise strength (this will be assessed every 4 hours).
- Cumulative 24 and 48 hour opioid analgesic use.
- Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24 hours.
- Conditions
- Postoperative Pain
- Being tested
- Clonidine, Placebo, Ropivacaine, Dexamethasone, Epinephrine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
50 mcg Clonidine added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the treatment group.
PlaceboDrug
Normal saline added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the placebo group.
RopivacaineDrug
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
DexamethasoneDrug
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
EpinephrineDrug
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | 50 mcg clonidine + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution Receives: Drug: Clonidine; Drug: Ropivacaine; Drug: Dexamethasone; Drug: Epinephrine |
| Placebo | Placebo comparator | 0.5 ml normal saline + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution Receives: Drug: Placebo; Drug: Ropivacaine; Drug: Dexamethasone; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
the time interval between placement of adductor canal block to the first request of opioid analgesic by patients
Measured: 24 hours for primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start22 May 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borzoo Farhang, University of Vermont
- Investigators
- Borzoo Farhang, DO, Principal investigator, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057015
- Sponsor's protocol ID
- CHRMS 17-0107
- Status last verified
- May 2018
- First submitted
- 13 Feb 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Clonidine to Ropivacaine in Adductor Canal Block for Postoperative Pain Relief in Total Knee Arthroplasty: A Prospective Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03057015
- Acronym / sponsor ID
- CHRMS 17-0107
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 17 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.
Total knee arthroplasty (knee replacement) is a common orthopedic procedure for osteoarthritis. This procedure is performed either under general anesthesia or spinal anesthesia; after the procedure in the recovery room, these patients undergo adductor canal block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve the quality of pain control as well as the duration of pain relief. The primary local anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are epinephrine and dexamethasone.
There is conflicting data available in the literature regarding efficacy of addition of clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data assessing the efficacy of this medication in adductor canal blocks.
Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be given to the acute pain service staff performing the nerve block. This will be mixed with local anesthetic solution and injected in the adductor canal under ultrasound guidance.
The primary outcome measure will be the duration of analgesia, which will be assessed as the time interval between placement of adductor canal block to the first request of opioid analgesic by patients (which will be obtained from hospital electronic medical records). Secondary outcomes will include:
- Duration of sensory block, which will be assessed as the time interval between injection of local anesthetic and report of postoperative pain of 3 or more on an 11 point scale (0=no pain; 10= worst pain imaginable) by the patient (this will be assessed every 4 hours).
- Duration of motor block, which will be assessed as the time interval between the onset of motor block to complete recovery of motor block by assessing straight leg raise strength (this will be assessed every 4 hours).
- Cumulative 24 and 48 hour opioid analgesic use.
- Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: Clonidine, Drug: Ropivacaine, Drug: Dexamethasone, Drug: Epinephrine50 mcg clonidine + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Ropivacaine, Drug: Dexamethasone, Drug: Epinephrine0.5 ml normal saline + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ages 18 and older
- ASA physical status classification system I, II and III (healthy patient or patient with mild to moderate systemic disease)
- Patient coming in for elective total knee arthroplasty under general or neuraxial anesthesia and postoperative adductor canal block
- Patients staying for at least 24 hrs post operatively
- Patients who provide informed consent
Key exclusion criteria (5 listed)
- History of recent common colds, upper respiratory infections or immune deficiencies
- Patients allergic to clonidine
- Pregnant women (all women of childbearing age undergo pregnancy testing prior to anesthesia as per UVMMC peri-operative protocol)
- Patients who are already on chronic clonidine therapy for management of blood pressure
- Patients on chronic opioid therapy defined as more than 10 mg of oxycodone per day (or equivalent doses of other opioid analgesics)
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 |
|---|---|---|
| Clonidine50 mcg Clonidine added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the treatment group. | Drug | Clonidine |
| PlaceboNormal saline added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the placebo group. | Drug | Placebo |
| RopivacaineClonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups. | Drug | Clonidine, Placebo |
| DexamethasoneClonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups. | Drug | Clonidine, Placebo |
| EpinephrineClonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups. | Drug | Clonidine, Placebo |
Primary outcome
Duration of Analgesia
Time frame: 24 hours for primary outcome
the time interval between placement of adductor canal block to the first request of opioid analgesic by patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Borzoo Farhang, DO principal investigator
University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine, Ropivacaine and Dexamethasone in people with Postoperative Pain, run by University of Vermont at 1 site in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 3 May 2018. 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Borzoo Farhang, DO (8028819927, borzoo.farhang@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Analgesia (time frame: 24 hours for primary outcome). 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 3 May 2018.