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

Not Applicable

Completed

• Conditions: Femoral Neck Fractures
• Interventions: Drug: Saline; Drug: Ropivacaine; Drug: Epinephrine

• Registration Number: NCT02585011
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-23
• Study Start: 2015-12
• Primary Completion: 2018-05-13
• Study Completion: 2018-05-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Single shot during surgery.150 ml saline
Ropivacaine	Ropivacaine	Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)
Ropivacaine	Epinephrine	Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)

Primary Outcome Measures

Name	Time	Method
Pain sensation during mobilization in the post-anesthesia care unit.	24 hours (day of 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?

Secondary Outcome Measures

Name	Time	Method
Total consumption of opioids on the first postoperative day	48 hrs (first postoperative day)
Pain during mobilization on the day after surgery	48 hours (first postoperative day)	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?

Trial Locations

Locations (1)

Ortopedisk forskningssenter, St.Olavs Hospital; 🇳🇴 Trondheim, Norway