The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks

NCT ID: NCT00616603

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

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.

Group Type: OTHER

Ropivacaine

Intervention Type: DRUG

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

Normal Saline

Intervention Type: DRUG

2ml of normal saline given once intravenously.

Group B

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

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Normal Saline

Intervention Type: DRUG

2ml of normal saline given once intravenously.

Group C

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

2ml(8mg)Dexamethasone given once intravenously.

Interventions

Ropivacaine

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Dexamethasone

2ml(8mg)Dexamethasone given once intravenously.

Intervention Type: DRUG

Normal Saline

2ml of normal saline given once intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

57164

Identifier Type: -

Identifier Source: org_study_id