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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359136
• Other study ID #: 2012/1999
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: March 30, 2017
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients receiving total hip arthroplasty in the study period

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• local infiltration anesthesia using Ropivacaine and Epinephrine
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.
• local infiltration anesthesia using saline
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.
• Multimodal analgesic regimen
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.

Locations

Country	Name	City	State
Norway	St.Olavs Hospital, Department of Orthopedics	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain assessed by numeric rating scale	assessed by numeric rating scale	1 day (first postoperative day)