Overview

This trial is active, not recruiting.

Conditions amputation, phantom limb pain, stump pain
Treatment perineural ropivicaine
Phase phase 4
Sponsor University of California, San Diego
Collaborator National Institute of General Medical Sciences (NIGMS)
Start date October 2008
End date December 2015
Trial size 18 participants
Trial identifier NCT00771862, Phantom limb pain PREVENTION

Summary

The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.
perineural ropivicaine
Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.
(Active Comparator)
4-5 days of perineural ropivacaine 0.4% infusion.
perineural ropivicaine
Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.

Primary Outcomes

Measure
The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.
time frame: Week 4

Secondary Outcomes

Measure
Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)
time frame: Preoperative, then days 3, 8, 28, 84, and 365
Emotional Functioning: Beck Depression Inventory
time frame: Preoperative, then days 28 and 365
The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively - currently without phantom limb and/or stump pain in a previously-amputated limb - ages 18 years or older - desiring perineural infusion for up to 6 days - willing to have an ambulatory infusion following hospital discharge Exclusion Criteria: - hepatic or renal failure - allergy to the study medications - pregnancy - incarceration - possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Additional Information

Official title Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks
Principal investigator Brian Ilfeld, M.D., M.S.
Description Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain. Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment. Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of California, San Diego.