Phase 4
N=52
Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain.
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01597479 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day — 8.3; 80.8; 4.2; 42.3 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levobupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day |
8.3; 80.8; 4.2; 42.3 | — |
| SECONDARY Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron |
8; 24; 5; 21; 2; 17 | — |
Summary
The aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve blocks on target nerves (radial and median nerve blocks at the elbow), using low volume and low concentration of long acting local anesthetic provide better postoperative pain control compare with systemic analgesia alone after thumb resection arthroplasty (TRA) due to a prolonged selective sensitive block on the tissue trauma.
Eligibility Criteria
Inclusion Criteria
- Age more than 18 years.
- Ambulatory TRA.
- Free acceptance to participate in the study, with informed consent signed by patient, guardian or family member.
Exclusion Criteria
- Age less than 18 years
- Pregnancy.
- Inability to provide informed consent.
- Allergy to amide local anesthetics/NSAIDs
- Preexisting chronic pain treated with opioids.
- Neuropathy involving the extremity undergoing surgery or neurological-cognitive deficits that may interfere in the assessement.
- Contraindications to dPNBs
Data sourced from ClinicalTrials.gov (NCT01597479). 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.