Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic

NCT01511211 | Withdrawn Phase 4

• 1 other identifier: UNMLAMLLDEX
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Randomized Double blinded controlled trial on the effect of adding dexamethasone to Ropivacaine on the duration of pain relief for ultrasound guided femoral, obturator and popliteal block after total knee replacement surgery.

Conditions

Pain; Total Knee Arthroplasty

Keywords

Dexamethasone; lower limb block; ultrasound guided femoral nerve block; ultrasound guided obturator nerve block; ultrasound guided sciatic nerve block; ropivacaine; total knee arthroplasty; Post surgical pain after total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  Duration of analgesia defined as the time interval between the end of local anesthetic injection and the patient's first report of pain in the knee.

  72 hours or first report of pain in the knee which ever is earliest

Secondary Outcomes (3)

• Duration of motor blockade

  72 hour or first return of motor function

• Duration of sensory blockade

  72 hours or first report of sensory recovery

• Complete sensory return

  72 hours or when the patient first reports complete sensation

Study Arms (2)

Ropivacaine + Dexamethasone Combination

EXPERIMENTAL

Drug: Dexamethasone

Ropivacaine-Only Block

ACTIVE COMPARATOR

Drug: Ropivacaine

Interventions

Dexamethasone DRUG

2 cc of 4 mg/cc dexamethasone will be added to 38 cc of 0.5% ropivacaine solution. Of this combination, 15 cc will be used for a femoral nerve block, 20 cc for the popliteal nerve block, and 5 cc for the obturator nerve block. In addition, 2 cc of normal saline will be added to the patient's IV to maintain blinding.

Also known as: Decadron

Ropivacaine + Dexamethasone Combination

Ropivacaine DRUG

2 cc of normal saline will be added to 38 cc of 0.5% ropivacaine solution. Of this combination, 15 cc will be used for the femoral nerve block, 20 cc for the popliteal nerve block, and 5 cc for the obturator nerve block. In addition, 2 cc of 4 mg/cc dexamethasone will be added to the patient's IV.

Also known as: Naropin

Ropivacaine-Only Block

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists physical status I to III,
• Aged 18 and above,
• Undergoing total knee replacement.

You may not qualify if:

• Body mass index of more than 45 kg/m2 (higher chance of failure)
• Weight less than 70 kg
• Diabetes
• Injection site deformities
• Infection at the injection site
• Existing peripheral neuropathy
• Allergy to LA agents
• Contraindications to dexamethasone
• Patients with severe PONV
• Patients with peptic ulceration or upper GI bleed of unknown origin
• Coagulopathy
• Any other contraindication to lower limb peripheral nerve block

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Dexamethasone; Calcium Dobesilate; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Nicholas Lam, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (1)