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NCT Number: NCT03117140

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

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.

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Key information

Conditions

Anesthesia, Local

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have or are:
  • Orthopedics service patients having shoulder surgery
  • ASA(American Society of Anesthesiologists) class I, II, or III.
  • Patients at least 18 years old but less than 71 years old.
  • Patients giving informed consent.
  • Non-Emergency Surgery

Exclusion criteria

  • Patients who have or are:
  • An inability to cooperate during the block placement.
  • Neuropathy of the planned extremity to block
  • Diabetes
  • Documented Kidney Disease
  • Documented Liver Disease
  • A lack of or inability to give informed consent.
  • Currently incarcerated.
  • Pregnant

Treatment and study plan

Ropivacaine 0.75%

Drug

Only ropivacaine 0.75% is administered for this arm of the interscalene block

Other names: Naropin

Ropivacaine 0.75% + 300 mcg Buprenorphine

Drug

Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block

Other names: Naropin + Buprenex

Ropivacaine 0.75% + 75 mcg clonidine

Drug

Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block

Other names: Naropin + Duraclon

Ropivacaine 0.75% + 8 mg dexamethasone

Drug

Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block

Other names: Naropin + Decadron

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Melinda Seering

Other

Registry information

Official study title

A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2017
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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