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

Melinda Seering

Status and phase: Completed; Phase 4

Conditions: Anesthesia, Local

Treatments: Drug: Ropivacaine 0.75%; Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine; Drug: Ropivacaine 0.75% + 8 mg dexamethasone; Drug: Ropivacaine 0.75% + 75 mcg clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03117140

201304727

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups

Plain Ropivacaine

Active Comparator group

Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Treatment:

Drug: Ropivacaine 0.75%

Ropivacaine + Buprenorphine

Experimental group

Description:

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Treatment:

Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine

Ropivacaine + Clonidine

Experimental group

Description:

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Treatment:

Drug: Ropivacaine 0.75% + 75 mcg clonidine

Ropivaciane + Dexamethasone

Experimental group

Description:

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Treatment:

Drug: Ropivacaine 0.75% + 8 mg dexamethasone