Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

NCT ID: NCT01277159

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-12-31

Brief Summary

Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Conditions

Patients Undergoing Ankle Surgery

Study Design

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

Study Groups

Control Nerve Block. IV Dexamethasone (4 mg).

Control Nerve Block. IV Dexamethasone (4 mg).

Group Type: EXPERIMENTAL

A. Control Nerve Block. IV Dexamethasone (4 mg).

Intervention Type: DRUG

A. Control Nerve Block. IV Dexamethasone (4 mg).

Nerve Block with Dexamethasone (4 mg). IV saline.

B. Nerve Block with Dexamethasone (4 mg). IV saline.

Group Type: EXPERIMENTAL

B. Nerve Block with Dexamethasone (4 mg). IV saline.

Intervention Type: DRUG

B. Nerve Block with Dexamethasone (4 mg). IV saline.

Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp

Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)

Group Type: EXPERIMENTAL

C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)

Intervention Type: DRUG

C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)

Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (

Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).

Group Type: EXPERIMENTAL

D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).

Intervention Type: DRUG

D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).

Nerve Block with Dexamethasone (4 mg) / block Buprenorphine

Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Group Type: EXPERIMENTAL

E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).

Intervention Type: DRUG

E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Interventions

A. Control Nerve Block. IV Dexamethasone (4 mg).

A. Control Nerve Block. IV Dexamethasone (4 mg).

Intervention Type: DRUG

B. Nerve Block with Dexamethasone (4 mg). IV saline.

B. Nerve Block with Dexamethasone (4 mg). IV saline.

Intervention Type: DRUG

C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)

C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)

Intervention Type: DRUG

D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).

D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).

Intervention Type: DRUG

E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).

E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients of Dr Levine or Dr Roberts.

2. Scheduled for discharge from HSS after foot or ankle surgery.

3. A single-injection popliteal fossa nerve block is judged appropriate.

4. Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).

5. Patients aged 18-75 years.

Exclusion Criteria

• Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
• Bilateral surgery
• Chronic pain (defined as regular use of opioid analgesics for > 3 months).
• Chronic use of steroids (defined as regular use of steroids for > 3 months).
• Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
• Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
• Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
• Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Urban

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2012-042

Identifier Type: -

Identifier Source: org_study_id