Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?

Phase 4

Completed

• Conditions: Knee Rheumatism; Knee Osteoarthritis
• Interventions: Drug: Obturator nerve regional block; Drug: Saline; Drug: Adductor canal regional block

• Registration Number: NCT03326999
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.

Detailed Description

There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-31
• Study Start: 2017-12-11
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Results First Submitted: 2020-08-13
• Results First Submitted QC: 2020-08-13
• Results First Posted: 2020-08-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients scheduled to undergo total knee arthroplasty
• Planned use of regional anesthesia for procedure
• Willing and able to provide informed consent

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Exclusion Criteria

• Patients on immunosuppressive therapy
• Patients with history of diabetes
• Patients with lower limb neuropathy
• Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
• Patients with known allergy or intolerance to any drug used in the study
• Patients with history of alcohol or drug abuse
• Patients with history of intolerance of nonsteroidal anti-inflammatory drugs
• Patients with hepatic or renal insufficiency
• ASA score of 4 or greater

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Saline	Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Investigational arm	Obturator nerve regional block	Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
Investigational arm	Adductor canal regional block	Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
Control arm	Adductor canal regional block	Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline

Primary Outcome Measures

Name	Time	Method
Morphine Equivalence Consumption	up to 24 hours after surgery	Total amount of opioids consumed

Secondary Outcome Measures

Name	Time	Method
Pain Score	1, 6, 12, and 24 hours after surgery	Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
Number of Participants With Nausea or Vomiting	up to 24 hours after surgery	Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
Time to Ambulation	on postoperative day 1 after surgery	The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
Time to Breakthrough Pain Medication	up to post operative day 2 after surgery	Time before pain medication needed for breakthrough pain
Analgesia Satisfaction Score	2 weeks after surgery	Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States