Distal Radius Fracture Clinical Trial
Official title:
Preoperative Versus Postoperative Peripheral Nerve Block for Pain Control After Ankle and Wrist Fracture Surgery
NCT number | NCT05391464 |
Other study ID # | PNBtrial |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 16, 2022 |
Est. completion date | June 18, 2025 |
Surgical treatment for patients with a fracture of the ankle or distal radius is commonly offered on an outpatient basis. Patients are routinely discharged from hospital within 4 hours of their procedure. The surgery is commonly performed under peripheral nerve block with sedation, or under general anesthesia with postoperative peripheral nerve block, (if required for analgesic purposes). It is unclear which of these two strategies offers patients superior pain relief in the first few days following surgery. This trial aims to compare the pain intensity and analgesic medication consumption between patients in these two groups.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | June 18, 2025 |
Est. primary completion date | May 18, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Within 2 weeks of injury - Isolated fracture requiring surgery - Outpatient Exclusion Criteria: - Multiple fractures - Inpatients - Cognitive impairment - Unable to comply with follow-up - No means of telephone contact - Contraindication to peripheral nerve block |
Country | Name | City | State |
---|---|---|---|
United States | MaineGeneral Medical Center | Augusta | Maine |
Lead Sponsor | Collaborator |
---|---|
MaineGeneral Health |
United States,
Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31. — View Citation
Fang J, Shi Y, Du F, Xue Z, Cang J, Miao C, Zhang X. The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 12;21(1):47. doi: 10.1186/s12871-021-01267-z. — View Citation
Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11. — View Citation
Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. Erratum in: J Orthop Trauma. 2013 Mar;27(3):181. — View Citation
Hsu JR, Mir H, Wally MK, Seymour RB; Orthopaedic Trauma Association Musculoskeletal Pain Task Force. Clinical Practice Guidelines for Pain Management in Acute Musculoskeletal Injury. J Orthop Trauma. 2019 May;33(5):e158-e182. doi: 10.1097/BOT.0000000000001430. Review. — View Citation
Kanto K, Lähdeoja T, Paavola M, Aronen P, Järvinen TLN, Jokihaara J, Ardern CL, Karjalainen TV, Taimela S. Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome. BMC Med Res Methodol. 2021 Mar 6;21(1):45. doi: 10.1186/s12874-021-01241-w. — View Citation
Laigaard J, Pedersen C, Rønsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021 May;126(5):1029-1037. doi: 10.1016/j.bja.2021.01.021. Epub 2021 Mar 5. — View Citation
Richebé P, Rivat C, Liu SS. Perioperative or postoperative nerve block for preventive analgesia: should we care about the timing of our regional anesthesia? Anesth Analg. 2013 May;116(5):969-970. doi: 10.1213/ANE.0b013e31828843c9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Analgesic consumption | Total milligram morphine equivalents, and nonopioid analgesics | 24 hours, 48 hours, 72 hours postop | |
Other | Rebound pain | Proportion of participants experiencing rebound pain (defined as visual analogue scale pain of 3 or less, climbing to 7 or more) after PNB. | First 72 hours postop | |
Primary | Pain 24 hours | Patient-rated measure, 0-10 visual analogue scale | 24 hours postop | |
Secondary | Pain 12 hours | 0-10 visual analogue scale | 12 hours postop | |
Secondary | Nausea and Vomiting 24 hours | 0-10 visual analogue scale | 24 hours postop | |
Secondary | Pain Functional Activity Scale 24 hours | A - No limitation, minimal pain; B - Mild limitation, moderate to severe pain; C - Severe limitation, can't perform due to severe pain. Four domains: Getting dressed, Preparing food, Moving around, Sleeping | 24 hours postop | |
Secondary | Pain Functional Activity Scale 48 hours | A - No limitation, minimal pain; B - Mild limitation, moderate to severe pain; C - Severe limitation, can't perform due to severe pain. Four domains: Getting dressed, Preparing food, Moving around, Sleeping | 48 hours postop | |
Secondary | Pain 48 hours | 0-10 visual analogue scale | 48 hours postop |
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