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

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Mount Sinai Health System

Status and phase

Completed
Phase 4

Conditions

Knee Rheumatism
Knee Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03326999
GCO 17-2153

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Investigational arm
Experimental group
Description:
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
Treatment:
Drug: Obturator nerve regional block
Drug: Adductor canal regional block
Control arm
Sham Comparator group
Description:
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Treatment:
Drug: Saline
Drug: Adductor canal regional block

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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