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Completed

NCT Number: NCT01277159

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

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?

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Key information

Conditions

Patients Undergoing Ankle Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of Dr Levine or Dr Roberts.
  • Scheduled for discharge from HSS after foot or ankle surgery.
  • A single-injection popliteal fossa nerve block is judged appropriate.
  • Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
  • 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)

Treatment and study plan

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

Drug

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

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

Drug

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

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

Drug

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

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

Drug

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

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

Drug

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

Primary outcomes

  1. Time it Takes for Nerve Block to Wear Off

    Time frame: up to 72 hours

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

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 14, 2011
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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