Back to results

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

Primary Purpose

Knee Osteoarthritis, Knee Rheumatism

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Obturator nerve regional block

Adductor canal regional block

Saline

Sponsored by

Icahn School of Medicine at Mount Sinai

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring adductor canal regional block, obturator nerve regional block, total knee arthroplasty, knee replacement surgery, Knee rheumatoid arthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Investigational arm

Control arm

Arm Description

Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine

Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline

Outcomes

Primary Outcome Measures

Morphine Equivalence Consumption

Total amount of opioids consumed

Secondary Outcome Measures

Pain Score

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

Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited

Time to Ambulation

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

Time before pain medication needed for breakthrough pain

Analgesia Satisfaction Score

Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.

Full Information

NCT ID

First Posted

October 27, 2017

Last Updated

September 10, 2020

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT03326999

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 11, 2017 (Actual)

Primary Completion Date

December 18, 2018 (Actual)

Study Completion Date

December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Knee Rheumatism

Keywords

adductor canal regional block, obturator nerve regional block, total knee arthroplasty, knee replacement surgery, Knee rheumatoid arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational arm

Arm Type

Experimental

Arm Description

Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine

Arm Title

Control arm

Arm Type

Sham Comparator

Arm Description

Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline

Intervention Type

Drug

Intervention Name(s)

Obturator nerve regional block

Other Intervention Name(s)

bupivacaine

Intervention Description

Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.

Intervention Type

Drug

Intervention Name(s)

Adductor canal regional block

Intervention Description

Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Saline as placebo comparator

Primary Outcome Measure Information:

Title

Morphine Equivalence Consumption

Description

Total amount of opioids consumed

Time Frame

up to 24 hours after surgery

Secondary Outcome Measure Information:

Title

Pain Score

Description

Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced

Time Frame

1, 6, 12, and 24 hours after surgery

Title

Number of Participants With Nausea or Vomiting

Description

Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited

Time Frame

up to 24 hours after surgery

Title

Time to Ambulation

Description

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 Frame

on postoperative day 1 after surgery

Title

Time to Breakthrough Pain Medication

Description

Time before pain medication needed for breakthrough pain

Time Frame

up to post operative day 2 after surgery

Title

Analgesia Satisfaction Score

Description

Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.

Time Frame

2 weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Jeng, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

27171822

Citation

Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs