Clinical trial NCT03326999: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Knee Rheumatism
Keywords: adductor canal regional block
obturator nerve regional block
total knee arthroplasty
knee replacement surgery
Knee rheumatoid arthritis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morphine Equivalence Consumption
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: Pain Score
timeFrame: 1, 6, 12, and 24 hours after surgery
measure: Number of Participants With Nausea or Vomiting
timeFrame: up to 24 hours after surgery
measure: Time to Ambulation
timeFrame: on postoperative day 1 after surgery
measure: Time to Breakthrough Pain Medication
timeFrame: up to post operative day 2 after surgery
measure: Analgesia Satisfaction Score
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christina Jeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.