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

NCT02585011 | Completed

• 1 other identifier: 2015/1201
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures

Keywords

Hemiarthroplasty; Anesthesia, Local; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain during mobilization on the day after surgery

  48 hours (first postoperative day)

• Total consumption of opioids on the first postoperative day

  48 hrs (first postoperative day)

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)

Drug: Ropivacaine; Drug: Epinephrine

Placebo

PLACEBO COMPARATOR

Single shot during surgery.150 ml saline

Drug: Saline

Interventions

Ropivacaine DRUG

Ropivacaine

Epinephrine DRUG

Ropivacaine

Saline DRUG

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Ortopedisk forskningssenter, St.Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Femoral Neck Fractures; Pain, Postoperative

Interventions

Ropivacaine; Epinephrine; Sodium Chloride

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Olav Foss, Phd

  Ortopedisk forskningssenter, St.Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 23, 2015
• Study Start: December 1, 2015
• Primary Completion: May 13, 2018
• Study Completion: May 13, 2018
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

NO (1)