The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks

NCT00616603 | Terminated Results

• 1 other identifier: 57164
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty.; Sciatic nerve Blocks.; Dexamethasone.

Outcome Measures

Primary Outcomes (1)

• Duration of Sciatic Nerve Block

  Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores

  from the time the block was placed up to 24 hours

Study Arms (3)

Group A

OTHER

This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.

Drug: Ropivacaine; Drug: Normal Saline

Group B

EXPERIMENTAL

Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.

Drug: Ropivacaine; Drug: Dexamethasone; Drug: Normal Saline

Group C

ACTIVE COMPARATOR

Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.

Drug: Ropivacaine; Drug: Dexamethasone

Interventions

Ropivacaine DRUG

20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.

Group A; Group B; Group C

Dexamethasone DRUG

8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.

Group B

Normal Saline DRUG

2ml of normal saline given once intravenously.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 yrs, male or female subjects.
• Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
• American Society of Anesthesiology Class 1,2,3,or 4.
• Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
• Weight \> or equal to 60kg.

You may not qualify if:

• Any allergies or hypersensitivity to ropivacaine or dexamethasone.
• Subject is on chronic steroids preoperatively for any reason.
• History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
• History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
• Contraindication to placement of sciatic nerve block.
• Sciatic block placement failure.
• Subject mistakenly receives steroids intraoperatively.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Ropivacaine; Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

PI left the institution and data analysis cannot be summarized due to poor data integrity.

Results Point of Contact

• Title: Patricia Moore, CCRP
• Organization: Loma Linda University Department of Anesthesiology

pamoore@llu.edu

909-558-8493

Study Officials

• Charles Lee, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: August 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 11, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-06

Locations

US (1)