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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2018-12-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Knee Rheumatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Investigational arm

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

Group Type EXPERIMENTAL

Obturator nerve regional block

Intervention Type DRUG

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

Adductor canal regional block

Intervention Type DRUG

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

Control arm

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

Group Type SHAM_COMPARATOR

Adductor canal regional block

Intervention Type DRUG

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

Saline

Intervention Type DRUG

Saline as placebo comparator

Interventions

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Obturator nerve regional block

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

Intervention Type DRUG

Adductor canal regional block

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

Intervention Type DRUG

Saline

Saline as placebo comparator

Intervention Type DRUG

Other Intervention Names

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bupivacaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No