Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

NCT01690663 | Completed Results DMC

• 1 other identifier: 815628
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.

Conditions

Post Surgical Pain

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Variable is Post Operative Sensory Block Duration

  This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.

  days 1, 2, and day 7

Secondary Outcomes (1)

• The Secondary Outcome Variable is Post Operative Motor Block Duration

  days 1, 2, and day 7

Study Arms (4)

Bupivacaine 0.25% mixed with 1ml normal saline

PLACEBO COMPARATOR

Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)

Drug: Bupivacaine 0.25%; Drug: normal saline

Bupivacaine 0.25% with 1mg dexamethasone (1ml)

ACTIVE COMPARATOR

Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)

Drug: Bupivacaine 0.25%; Drug: Dexamethasone

Bupivacaine 0.25% mixed with 2mg dexamethasone

ACTIVE COMPARATOR

Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)

Drug: Bupivacaine 0.25%; Drug: Dexamethasone

Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml

ACTIVE COMPARATOR

Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml

Drug: Bupivacaine 0.25%; Drug: Dexamethasone

Interventions

Bupivacaine 0.25% DRUG

Bupivacaine 0.25% mixed with 1ml normal saline; Bupivacaine 0.25% mixed with 2mg dexamethasone; Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml; Bupivacaine 0.25% with 1mg dexamethasone (1ml)

Dexamethasone DRUG

Bupivacaine 0.25% mixed with 2mg dexamethasone; Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml; Bupivacaine 0.25% with 1mg dexamethasone (1ml)

normal saline DRUG

placebo

Bupivacaine 0.25% mixed with 1ml normal saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
• Ability to sign informed consent.
• Ability to follow study protocol, and speak, read and write in English.
• Must have valid phone number for follow-up purpose.
• Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.

You may not qualify if:

• Patient younger than 18 years old and older than age 70
• Patient refusal to sign consent
• Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
• Allergy to any of the protocol medications
• Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
• Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19139, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

First, all information was collected via telephone call during the recovery period at home, during which recall may be inaccurate. Second, we did not control the intravenous dexamethasone use, which could potentially affect the analgesia duration.

Results Point of Contact

• Title: Jiabin Liu, MD, PhD
• Organization: the University of Pennsylvania

jiabin.liu@uphs.upenn.edu

215-573-8208

Study Officials

• Jiabin Liu, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 4, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-03

Locations

US (1)