N/A
N=70
Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses
Pain, Acute · Anesthesia, Local · Trauma Injury
Bottom Line
View on ClinicalTrials.gov: NCT04458467 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Average Pain Queried on First Postoperative Day — 3; 0.0 score on a scale — p=0.033
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Infusion (Device); Automated Intermittent Boluses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Queried on First Postoperative Day |
3; 0.0 | 0.033 sig |
| PRIMARY Duration of Infusion |
74; 119 | <0.001 sig |
| SECONDARY Worst Pain |
5.3; 3.3; 6.9; 4.6; 4.9; 3.6 | — |
| SECONDARY Average Pain |
3.0; 1.6; 4.1; 2.0; 3.0; 1.6 | — |
| SECONDARY Least Pain |
0.2; 0.1; 1.1; 0.7; 1.0; 0.4 | — |
| SECONDARY Current Pain |
2.8; 1.7; 2.4; 1.6; 1.9; 1.2 | — |
| SECONDARY Opioid Consumption |
1.4; 0.7; 2.0; 0.9; 1.7; 0.7 | — |
| SECONDARY Sleep Disturbances Due to Pain |
1.0; 0.4; 1.5; 0.5; 0.8; 0.2 | — |
| SECONDARY Numbness in Foot and Ankle |
7.5; 8.9; 5.1; 7.9; 4.5; 7.4 | — |
Summary
This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to automated boluses with PCA for continuous popliteal sciatic nerve blocks. The goal will be to determine the relationship between method of local anesthetic administration (continuous with PCA initiated at discharge vs. intermittent dosing with PCA with a 5-hour delay) for continuous peripheral nerve block and the resulting pain control and duration of analgesia.
Eligibility Criteria
Inclusion Criteria
- patients undergoing painful foot and/or ankle surgery with a planned popliteal sciatic perineural catheter for postoperative analgesia
- age 18 years or older.
Exclusion Criteria
- Current daily opioid use within the previous 4 weeks
- Clinical neuro-muscular deficit of either the sciatic nerve and its branches and/or innervating muscles
- Morbid obesity [weight > 35 kg/m2]; surgery outside of ipsilateral sciatic and saphenous nerve distributions
- Pregnancy [as determined by a urine pregnancy test prior to any study interventions]
- Incarceration.
Data sourced from ClinicalTrials.gov (NCT04458467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.