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

Sponsor

St. Olavs Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02359136

Collaborator

(none)

116

Enrollment

Location

Arms

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip	Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine Procedure: local infiltration anesthesia using saline Procedure: Multimodal analgesic regimen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: LIA placebo local infiltration anesthesia using saline i addition to multimodal analgesic regimen	Procedure: 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. Procedure: 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.
Experimental: LIA Ropivacaine local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen	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. Procedure: 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.

Arm

Intervention/Treatment

Placebo Comparator: LIA placebo

local infiltration anesthesia using saline i addition to multimodal analgesic regimen

Procedure: 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.

Procedure: 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.

Experimental: LIA Ropivacaine

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

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.

Procedure: Multimodal analgesic regimen

Outcome Measures

Primary Outcome Measures

postoperative pain assessed by numeric rating scale [1 day (first postoperative day)]
assessed by numeric rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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