Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery

NCT01167907 | Completed Results FDA Device

• 1 other identifier: IRB00013823
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve. The purpose of this research study is to test whether the placement of a second nerve block catheter, rather than a single injection for the saphenous nerve block will improve pain relief and/or reduce pain medication needed after surgery enough to justify two nerve block catheters. There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake Forest University typically have a nerve block catheter placed next to the sciatic nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of local anesthetic is usually performed to block the saphenous nerve for 12-16 hours postoperatively.

Conditions

Orthopedic Surgery of Lower Extremity

Keywords

ankle; arthrodesis; internal fixation; bi/tri malleolar fracture

Outcome Measures

Primary Outcomes (1)

• Verbal Pain Scores

  The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved. "Verbal Pain Score" is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate "no pain" and is the best score Ten (10) is used to rate "the worst pain imaginable" and is the worst score

  48 hours post nerve blockade

Secondary Outcomes (5)

• Opioid Use

  48 hours post nerve blockade

• Nausea

  48 hours post nerve blockade

• Vomiting

  48 hour post nerve blockade

• Sleep Disturbance

  48 hours post nerve blockade

• Reduction of Quadriceps Strength

  24 hours post nerve blockade

Study Arms (2)

0.2% ropivacaine

EXPERIMENTAL

Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.

Device: 0.2% ropivacaine; Drug: saline

Saline

PLACEBO COMPARATOR

Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.

Drug: saline

Interventions

0.2% ropivacaine DEVICE

0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

Also known as: NAROPIN®

0.2% ropivacaine

saline DRUG

saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

0.2% ropivacaine; Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• surgery for unilateral ankle arthrodesis
• surgery for open reduction and internal fixation of bi/tri malleolar fracture

You may not qualify if:

• coagulation abnormalities
• history of opioid addiction
• current chronic pain therapy with high dsoe opioid
• allergy to study medication
• failure of the sciatic nerve catheter

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• I-Flow: collaborator

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Ankylosis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Robert S. Weller, MD
• Organization: Wake Forest School of Medicine

rweller@wakehealth.edu

336-716-7150

Study Officials

• Robert Weller, M.D.

  Wake Forest Univesity Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: August 31, 2018
• Results First Posted: December 8, 2017

Record last verified: 2018-07

Locations

US (1)