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

September 10, 2020 updated by: Christina Jeng, Icahn School of Medicine at Mount Sinai

Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
Drug: Obturator nerve regional block
Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
Other Names:
  • bupivacaine
Drug: Adductor canal regional block
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
Sham Comparator: Control arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Drug: Adductor canal regional block
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
Drug: Saline
Saline as placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Equivalence Consumption
Time Frame: up to 24 hours after surgery
Total amount of opioids consumed
up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 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
1, 6, 12, and 24 hours after surgery
Number of Participants With Nausea or Vomiting
Time Frame: up to 24 hours after surgery
Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
up to 24 hours after surgery
Time to Ambulation
Time Frame: 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.
on postoperative day 1 after surgery
Time to Breakthrough Pain Medication
Time Frame: up to post operative day 2 after surgery
Time before pain medication needed for breakthrough pain
up to post operative day 2 after surgery
Analgesia Satisfaction Score
Time Frame: 2 weeks after surgery
Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2017

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-2153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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