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

NCT03326999 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 17-2153
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Rheumatism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalence Consumption

  Total amount of opioids consumed

  up to 24 hours after surgery

Secondary Outcomes (5)

• Pain Score

  1, 6, 12, and 24 hours after surgery

• Number of Participants With Nausea or Vomiting

  up to 24 hours after surgery

• Time to Ambulation

  on postoperative day 1 after surgery

• Time to Breakthrough Pain Medication

  up to post operative day 2 after surgery

• Analgesia Satisfaction Score

  2 weeks after surgery

Study Arms (2)

Investigational arm

EXPERIMENTAL

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

Drug: Obturator nerve regional block; Drug: Adductor canal regional block

Control arm

SHAM COMPARATOR

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

Drug: Adductor canal regional block; Drug: Saline

Interventions

Obturator nerve regional block DRUG

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

Also known as: bupivacaine

Investigational arm

Adductor canal regional block DRUG

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

Control arm; Investigational arm

Saline DRUG

Saline as placebo comparator

Control arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 27171822 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Christina Jeng
• Organization: Icahn School of Medicine at Mount Sinai

christina.jeng@mountsinai.org

212-241-6426

Study Officials

• Christina Jeng, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christina Jeng MD Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: December 11, 2017
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: September 30, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)