Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty

Femoral Neck Fractures Clinical Trial

Official title:

Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585011
• Other study ID #: 2015/1201
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: May 13, 2018

Study information

• Verified date: September 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key prerequisites for early rehabilitation is optimized pain relief. Local infiltration anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this study it will be investigated whether a single shot with Ropivacaine reduces acute postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study will have a direct impact on patient treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 13, 2018
• Est. primary completion date: May 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• scheduled for hemiarthroplasty at St. Olavs Hospital

• competent and willing to give consent

• able to be mobilized in the PACU and in the trauma ward unit.

Exclusion Criteria:

• contraindications for spinal anesthesia, Dexamethasone, Dolcontin or Acetaminophene

• receiving general anesthesia

• patients operated on with an approach different to standard direct lateral surgery

• receiving osteosyntheses

• receiving femoral block less than 4 hours before surgery

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine

• Epinephrine

• Saline

Locations

Country	Name	City	State
Norway	Ortopedisk forskningssenter, St.Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain sensation during mobilization in the post-anesthesia care unit.	Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now?	24 hours (day of surgery)
Secondary	Pain during mobilization on the day after surgery	Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now?	48 hours (first postoperative day)
Secondary	Total consumption of opioids on the first postoperative day		48 hrs (first postoperative day)