Nerve Block for Pain Control After Fracture Surgery

NCT05391464 | Unknown

• 1 other identifier: PNBtrial
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Fractures; Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Pain 24 hours

  Patient-rated measure, 0-10 visual analogue scale

  24 hours postop

Secondary Outcomes (5)

• Pain 12 hours

  12 hours postop

• Nausea and Vomiting 24 hours

  24 hours postop

• Pain Functional Activity Scale 24 hours

  24 hours postop

• Pain Functional Activity Scale 48 hours

  48 hours postop

• Pain 48 hours

  48 hours postop

Other Outcomes (2)

• Analgesic consumption

  24 hours, 48 hours, 72 hours postop

• Rebound pain

  First 72 hours postop

Study Arms (2)

Peripheral Nerve Block

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided, single shot PNB using 30ml 0.5% bupivacaine with 10mg dexamethasone. The anatomic location of the block will be determined by the anesthesiologist and will vary according to fracture location and anticipated surgical approaches. Intraoperative sedation will be used at the discretion of the anesthetic team.

Procedure: Peripheral Nerve Block

General Anesthesia +/- PNB

ACTIVE COMPARATOR

GA will be administered in the operating room by a nurse anesthetist, with support from the anesthesiologist. GA will be induced with propofol and fentanyl and maintained with sevoflurane or desflurane and fentanyl. Doses will be determined by the anesthesiology team.

Procedure: Peripheral Nerve Block

Interventions

Peripheral Nerve Block PROCEDURE

Utilized preoperatively with sedation during surgery, or postoperatively for additional anesthesia after GA.

General Anesthesia +/- PNB; Peripheral Nerve Block

Eligibility Criteria

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

You may qualify if:

• Within 2 weeks of injury
• Isolated fracture requiring surgery
• Outpatient

You may not qualify if:

• Multiple fractures
• Inpatients
• Cognitive impairment
• Unable to comply with follow-up
• No means of telephone contact
• Contraindication to peripheral nerve block

Sponsors & Collaborators

• MaineGeneral Health: lead

Study Sites (1)

MaineGeneral Medical Center

Augusta, Maine, 04330, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 33390261 BACKGROUND

• 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.

  PMID: 33579199 BACKGROUND

• 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.

  PMID: 26869374 BACKGROUND

• 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. doi: 10.1097/BOT.0b013e3182638b25.

  PMID: 22732860 BACKGROUND

• 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.

  PMID: 30681429 BACKGROUND

• Kanto K, Lahdeoja T, Paavola M, Aronen P, Jarvinen 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.

  PMID: 33676417 BACKGROUND

• Laigaard J, Pedersen C, Ronsbo 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.

  PMID: 33678402 BACKGROUND

• Richebe 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. No abstract available.

  PMID: 23606468 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Wrist Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Wrist Injuries; Arm Injuries

Central Study Contacts

Stuart A Aitken, MBChB MD

CONTACT

2076218700; stuart.aitken@mainegeneral.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, single-center, superiority

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: May 16, 2022
• Primary Completion: May 18, 2025
• Study Completion: June 18, 2025
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)