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Trial record 82 of 326 for:    clonidine

Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

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ClinicalTrials.gov Identifier: NCT03117140
Recruitment Status : Completed
First Posted : April 17, 2017
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Melinda Seering, University of Iowa

Brief Summary:
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.

Condition or disease Intervention/treatment Phase
Anesthesia, Local Drug: Ropivacaine 0.75% Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine Drug: Ropivacaine 0.75% + 75 mcg clonidine Drug: Ropivacaine 0.75% + 8 mg dexamethasone Phase 4

Detailed Description:
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Study Start Date : December 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


Arm Intervention/treatment
Active Comparator: Plain Ropivacaine
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75%
Only ropivacaine 0.75% is administered for this arm of the interscalene block
Other Name: Naropin

Experimental: Ropivacaine + Buprenorphine
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
Other Name: Naropin + Buprenex

Experimental: Ropivacaine + Clonidine
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75% + 75 mcg clonidine
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
Other Name: Naropin + Duraclon

Experimental: Ropivaciane + Dexamethasone
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75% + 8 mg dexamethasone
Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Other Name: Naropin + Decadron




Primary Outcome Measures :
  1. Duration of Analgesia [ Time Frame: 1-3 days post-operative ]
    Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off


Secondary Outcome Measures :
  1. Block Set up Time [ Time Frame: Day one ]
    Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity

  2. Sensory Duration of Block [ Time Frame: Day 1-3 ]
    Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off

  3. Patient Reporting Vomiting at Home [ Time Frame: 1-3 days ]
    Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.

  4. Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) [ Time Frame: Post-op Day 0 (Baseline) ]
    Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at

  5. Number of Patients Reporting Nausea at Home [ Time Frame: 1-3 days ]
    Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.

  6. Number of Patients Reporting Nausea in the PACU [ Time Frame: Post-op day 0 (Baseline) ]
    PACU (Post-Anesthesia Care Unit) assessment of nausea

  7. Motor Duration of Block [ Time Frame: Day 1-3 ]
    Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off

  8. Number of Patients With Blood Pressure (BP) Changes in the PACU [ Time Frame: Post-op Day 0 (baseline) ]
    Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at

  9. Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area [ Time Frame: Post-op Day 0 (baseline) ]
    Blood pressure changes in Second Stage Recovery Area for patients was looked at

  10. Pain Score Reported by Patients at First Phone Call [ Time Frame: Day 1-3 ]
    Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.

  11. Number of Patients Reporting Itching in the PACU [ Time Frame: Post-op day 0 (baseline) ]
    Patients itching was assessed post-op in the PACU.

  12. Number of Patients Reporting Itching at Home [ Time Frame: 1-3 days ]
    Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.


Other Outcome Measures:
  1. Surgical Position [ Time Frame: Post-op Day 0 (Baseline) ]
    Surgical position was recorded

  2. Surgical Length [ Time Frame: Post op Day 0 (Baseline) ]
    Surgical length was recorded



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who have or are:

    1. Orthopedics service patients having shoulder surgery
    2. ASA(American Society of Anesthesiologists) class I, II, or III.
    3. Patients at least 18 years old but less than 71 years old.
    4. Patients giving informed consent.
    5. Non-Emergency Surgery

      Exclusion Criteria:

  • Patients who have or are:

    1. An inability to cooperate during the block placement.
    2. Neuropathy of the planned extremity to block
    3. Diabetes
    4. Documented Kidney Disease
    5. Documented Liver Disease
    6. A lack of or inability to give informed consent.
    7. Currently incarcerated.
    8. Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117140


Locations
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United States, Iowa
University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Melinda Seering
Investigators
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Principal Investigator: Melinda Seering, M.D. University of Iowa
  Study Documents (Full-Text)

Documents provided by Melinda Seering, University of Iowa:

Publications:

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Responsible Party: Melinda Seering, Clinical Assistant Profession, Prinicipal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03117140     History of Changes
Other Study ID Numbers: 201304727
First Posted: April 17, 2017    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Melinda Seering, University of Iowa:
Brachial Plexus Block
Clonidine
Dexamethasone
Buprenorphine
Additional relevant MeSH terms:
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Clonidine
Dexamethasone
Dexamethasone acetate
Buprenorphine
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Analgesics, Opioid
Narcotics
Analgesics
Narcotic Antagonists
Antihypertensive Agents
Sympatholytics