Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

NCT02359136 | Completed

• 1 other identifier: 2012/1999
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified. Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.

Conditions

Osteoarthritis, Hip

Keywords

Arthroplasty, Replacement, Hip; Anesthesia, Local; Ropivacaine; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• postoperative pain assessed by numeric rating scale

  assessed by numeric rating scale

  1 day (first postoperative day)

Study Arms (2)

LIA placebo

PLACEBO COMPARATOR

local infiltration anesthesia using saline i addition to multimodal analgesic regimen

Procedure: local infiltration anesthesia using saline; Procedure: Multimodal analgesic regimen

LIA Ropivacaine

EXPERIMENTAL

local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen

Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine; Procedure: Multimodal analgesic regimen

Interventions

local infiltration anesthesia using Ropivacaine and Epinephrine PROCEDURE

150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.

LIA Ropivacaine

local infiltration anesthesia using saline PROCEDURE

150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.

LIA placebo

Multimodal analgesic regimen PROCEDURE

All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.

LIA Ropivacaine; LIA placebo

Eligibility Criteria

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

You may qualify if:

• all patients receiving total hip arthroplasty in the study period

You may not qualify if:

• contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
• Patients who received general anaesthetic
• patients who will get a different operation than standard direct lateral surgery
• Patients with osteosynthesis to be removed in the same operation

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St.Olavs Hospital, Department of Orthopedics

Trondheim, 7006, Norway

Location

Related Publications (1)

• Hofstad JK, Winther SB, Rian T, Foss OA, Husby OS, Wik TS. Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty. Acta Orthop. 2015;86(6):654-8. doi: 10.3109/17453674.2015.1053775. Epub 2015 May 22.

  PMID: 25997827 RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Tina Strømdal Wik, md phd

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

NO (1)