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Minimal Opioid Use After Total Hip Replacement (THR)

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Periarticular injection (Deep injection)
Periarticular injection (Superficial injection)
Bupivacaine
Placebo
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Total Hip Replacement, Total Hip Arthroplasty

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
  • Planned use of regional anesthesia
  • Planned posterolateral surgical approach
  • Age Range 45-80
  • Ability to follow study protocol

Exclusion Criteria:

  • Any patient with age <45 or >80
  • Any patient with planned anterior surgical approach
  • Any patient with prior major ipsilateral hip surgery
  • Any patient intending to receive general anesthesia
  • Any patient with an ASA of IV
  • Any patient with insulin-dependent diabetes
  • Any patient with hepatic (liver) failure (history of cirrhosis or elevated LFT's)
  • Any patient with chronic renal (kidney) failure (formal diagnosis of renal disease of elevated creatinine)
  • Any patient with history of gastric (stomach) ulcer
  • Chronic opioid use (taking opioids for >3 mo duration on a daily basis)
  • Chronic analgesic use (i.e. lyrica, gabapentin) for >3 mo duration
  • Stress dose steroids
  • Use of antidepressants
  • Contraindications to aspirin
  • Allergy to any of the medications (or adhesives) involved in the study protocol
  • Dementia
  • Non-English speakers.

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Periarticular Injection (PAI)

Epidural Patient-Controlled Analg (EPCA)

PAI + EPCA

Arm Description

Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. Peri-articular injection in the operating room Combined Spinal Epidural with 1.5% Mepivacaine 4cc A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.

Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. Combined Spinal Epidural with 1.5% Mepivacaine 4cc A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.

Aspirin and nerve pain medications including duloxetine and clonidine Combined Spinal Epidural with 1.5% Mepivacaine 4cc Anesthetic, Antiemetic and peri-articular injection in the operating room A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.

Outcomes

Primary Outcome Measures

Opioid Use
Oral morphine equivalents, cumulative

Secondary Outcome Measures

Pain at Rest
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Pain With Activity
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Opioid Side Effects
via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.
Patient Satisfaction
via Likert scale. A higher score is a better outcome. the scale is from 0-10.
Post-operative Pain
via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.
Neuropathic Pain Assessed With S-LANSS
via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.
Quality of Recovery
Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome
Readiness for Discharge Time
When patient meets all readiness for discharge criteria
Blinding Assessment
What group do you think you were in
Opioid Consumption During the First 3 Days Post-op
Opioids consumed in the first 3 after surgery (cumulative consumption).
No Opioids Consumed
Number of patients who did not consume any opioids

Full Information

First Posted
March 13, 2017
Last Updated
July 26, 2022
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03090152
Brief Title
Minimal Opioid Use After Total Hip Replacement (THR)
Official Title
Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. In a previous study done by the investigators' group, epidural patient controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more favorable pain profile with ambulation, but greater side effects compared to injection of a peri-articular cocktail. The use of opioid was greater in the peri-articular injection group (PAI). There was no difference in length of stay. In view of the controversy over opioid use, the investigators would like to develop an optimal opioid sparing pain management approach by comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain control while minimizing opioid use and side-effects.
Detailed Description
Long acting narcotics or scheduled doses of narcotics are often used as part of a multimodal pain regimen. In this study, this is eliminated. Instead, it uses a cocktail of different drugs including intraoperative Ketamine use (NMDA receptor antagonist), intra-op Benadryl (to decrease excitation of nociceptors) and IV Tylenol. The narcotic free regimen starts preoperatively with the use of Aspirin,Clonidine patch, Cymbalta (Duloxetine), and is maintained both intraoperatively and post operatively. Baby ASA (81mg) is being used as an anti-inflammatory agent. A number of studies including the one by Morris et al. (2009), have shown via in vitro experiments that low dose aspirin decreases polymorphonuclear leukocyte and macrophage accumulation. It inhibits thromboxane making it an antithrombotic agent as well. The concern with aspirin has been major bleeding. Several studies in the orthopedic patient population using ≤81 mg of aspirin have shown that it does not increase bleeding (Cuellar, Mantz). At HSS, patients are routinely continued on baby aspirin when needed for its cardio protective effect. Devereaux in the POISE trial did show an increased risk of bleeding when ASA was given preoperatively at a dose of 200 mg. In our study, all patients will be given intravenous tranexamic acid which should mitigate against the risk of bleeding. Duloxetine is also being added. In a recent study done at HSS. Duloxetine was found to decrease the amount of opioid use and nausea. If found to be more effective with the use of EPCA vs. PAI or combination of the two, a new way of managing postop pain while minimizing Nnartcuoreti co fu Ssetu adsy per CDC recommendation will be helpful in managing patients post-operatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Total Hip Replacement, Total Hip Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periarticular Injection (PAI)
Arm Type
Active Comparator
Arm Description
Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. Peri-articular injection in the operating room Combined Spinal Epidural with 1.5% Mepivacaine 4cc A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Arm Title
Epidural Patient-Controlled Analg (EPCA)
Arm Type
Active Comparator
Arm Description
Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. Combined Spinal Epidural with 1.5% Mepivacaine 4cc A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Arm Title
PAI + EPCA
Arm Type
Experimental
Arm Description
Aspirin and nerve pain medications including duloxetine and clonidine Combined Spinal Epidural with 1.5% Mepivacaine 4cc Anesthetic, Antiemetic and peri-articular injection in the operating room A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Intervention Type
Procedure
Intervention Name(s)
Periarticular injection (Deep injection)
Intervention Description
Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Intervention Type
Procedure
Intervention Name(s)
Periarticular injection (Superficial injection)
Intervention Description
Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
EPCA: Bupivacaine 0.06%.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
EPCA: Saline.
Primary Outcome Measure Information:
Title
Opioid Use
Description
Oral morphine equivalents, cumulative
Time Frame
within 24 hours after surgery
Secondary Outcome Measure Information:
Title
Pain at Rest
Description
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Time Frame
Postoperative Day 1,2,3,7,90
Title
Pain With Activity
Description
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Time Frame
Postoperative Day 1,2,3,7,90
Title
Opioid Side Effects
Description
via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.
Time Frame
Postoperative Day 1,2
Title
Patient Satisfaction
Description
via Likert scale. A higher score is a better outcome. the scale is from 0-10.
Time Frame
Postoperative Day 1,2,3,7
Title
Post-operative Pain
Description
via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.
Time Frame
Postoperative Day 1
Title
Neuropathic Pain Assessed With S-LANSS
Description
via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.
Time Frame
Postoperative Day 7, Postoperative Day 90
Title
Quality of Recovery
Description
Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome
Time Frame
Postoperative Day 1,2,3
Title
Readiness for Discharge Time
Description
When patient meets all readiness for discharge criteria
Time Frame
From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
Title
Blinding Assessment
Description
What group do you think you were in
Time Frame
Assessed on day of discharge and on seventh post operative day
Title
Opioid Consumption During the First 3 Days Post-op
Description
Opioids consumed in the first 3 after surgery (cumulative consumption).
Time Frame
Postoperative day 0,1,2,3
Title
No Opioids Consumed
Description
Number of patients who did not consume any opioids
Time Frame
0 to 24 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon Planned use of regional anesthesia Planned posterolateral surgical approach Age Range 45-80 Ability to follow study protocol Exclusion Criteria: Any patient with age <45 or >80 Any patient with planned anterior surgical approach Any patient with prior major ipsilateral hip surgery Any patient intending to receive general anesthesia Any patient with an ASA of IV Any patient with insulin-dependent diabetes Any patient with hepatic (liver) failure (history of cirrhosis or elevated LFT's) Any patient with chronic renal (kidney) failure (formal diagnosis of renal disease of elevated creatinine) Any patient with history of gastric (stomach) ulcer Chronic opioid use (taking opioids for >3 mo duration on a daily basis) Chronic analgesic use (i.e. lyrica, gabapentin) for >3 mo duration Stress dose steroids Use of antidepressants Contraindications to aspirin Allergy to any of the medications (or adhesives) involved in the study protocol Dementia Non-English speakers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kethy Jules-Elysee, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Minimal Opioid Use After Total Hip Replacement (THR)

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