Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

NCT04860856 | Completed Phase 4 FDA Drug

• 1 other identifier: OS19011 IRB 2019-0366
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.

Conditions

Femur Fracture

Keywords

Femoral Intramedullary Rod; Hematoma Block

Outcome Measures

Primary Outcomes (1)

• Change in postoperative pain at 72 hours

  Postoperative pain will be assessed using a visual analog scale

  Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively

Secondary Outcomes (1)

• Narcotic usage

  Narcotic usage will be assessed through 72 hours postoperatively

Study Arms (2)

Hematoma block

EXPERIMENTAL

Fracture site injection of 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length).

Drug: 0.5% ropivacaine

Normal saline injection

PLACEBO COMPARATOR

Fracture site injection of 20ml of normal saline.

Drug: Normal Saline

Interventions

0.5% ropivacaine DRUG

The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.

Hematoma block

Normal Saline DRUG

20ml of normal saline

Normal saline injection

Eligibility Criteria

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

You may qualify if:

• Trauma patient at the University of Cincinnati Medical Center
• Skeletally mature patients
• Have an isolated, closed, acute traumatic femoral shaft fracture to be treated with a closed reduction and reamed intramedullary rod fixation

You may not qualify if:

• Unable to provide informed consent
• Member of a vulnerable patient population
• Have additional injuries
• Have a history of prior existing narcotic use or chronic pain management issues on presentation

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Related Publications (9)

• Alioto RJ, Furia JP, Marquardt JD. Hematoma block for ankle fractures: a safe and efficacious technique for manipulations. J Orthop Trauma. 1995 Apr;9(2):113-6. doi: 10.1097/00005131-199504000-00004.

  PMID: 7776029 BACKGROUND

• Bear DM, Friel NA, Lupo CL, Pitetti R, Ward WT. Hematoma block versus sedation for the reduction of distal radius fractures in children. J Hand Surg Am. 2015 Jan;40(1):57-61. doi: 10.1016/j.jhsa.2014.08.039. Epub 2014 Oct 11.

  PMID: 25306504 BACKGROUND

• Case RD. Haematoma block--a safe method of reducing Colles' fractures. Injury. 1985 Jul;16(7):469-70. doi: 10.1016/0020-1383(85)90168-8.

  PMID: 4030071 BACKGROUND

• Herrera JA, Wall EJ, Foad SL. Hematoma block reduces narcotic pain medication after femoral elastic nailing in children. J Pediatr Orthop. 2004 May-Jun;24(3):254-6. doi: 10.1097/00004694-200405000-00003.

  PMID: 15105718 BACKGROUND

• Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

  PMID: 11719741 BACKGROUND

• Koehler D, Marsh JL, Karam M, Fruehling C, Willey M. Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 15;99(6):512-519. doi: 10.2106/JBJS.16.00733.

  PMID: 28291185 BACKGROUND

• Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.

  PMID: 1749663 BACKGROUND

• Dimopoulou I, Anagnostou TL, Prassinos NN, Savvas I, Patsikas M. Effect of intrafragmentary bupivacaine (haematoma block) on analgesic requirements in dogs undergoing fracture repair. Vet Anaesth Analg. 2017 Sep;44(5):1189-1197. doi: 10.1016/j.vaa.2017.01.005. Epub 2017 Mar 6.

  PMID: 29100681 BACKGROUND

• Yue RA, Shah NS, Matar RN, Sagi HC. Efficacy of Hematoma Block After Intramedullary Rod Fixation of Femoral Shaft Fractures: A Prospective, Double-Blinded, Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):429-432. doi: 10.1097/BOT.0000000000002623.

  PMID: 37199424 DERIVED

MeSH Terms

Conditions

Femoral Fractures

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• He C S, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patients and the nursing staff who assess postoperative pain will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Blinded, randomized control trial

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 27, 2021
• Study Start: August 17, 2019
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)