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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326999
• Other study ID #: GCO 17-2153
• Status: Completed
• Phase: Phase 4
• Start date: December 11, 2017
• Est. completion date: December 18, 2018

Study information

• Verified date: September 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Rheumatism
• Osteoarthritis, Knee
• Rheumatic Diseases

Intervention

Drug:
• Obturator nerve regional block
Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
• Adductor canal regional block
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
• Saline
Saline as placebo comparator

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

Runge C, Børglum 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Equivalence Consumption	Total amount of opioids consumed	up to 24 hours after surgery
Secondary	Pain Score	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
Secondary	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	up to 24 hours after surgery
Secondary	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.	on postoperative day 1 after surgery
Secondary	Time to Breakthrough Pain Medication	Time before pain medication needed for breakthrough pain	up to post operative day 2 after surgery
Secondary	Analgesia Satisfaction Score	Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.	2 weeks after surgery