Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/17/2018 |
| Start Date: | February 17, 2017 |
| End Date: | November 15, 2017 |
Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either
multimodal single injection adductor canal block with sham infusion catheter or continuous
infusion of local anesthetic (control) for postoperative analgesia.
Primary end point is pain scores at 30 hours post performance of block procedure.
multimodal single injection adductor canal block with sham infusion catheter or continuous
infusion of local anesthetic (control) for postoperative analgesia.
Primary end point is pain scores at 30 hours post performance of block procedure.
The objective of this study is to determine if a single shot multimodal peripheral nerve
block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will
provide comparable (equivalent) analgesic control when compared to an adductor catheter. The
primary end point will be pain scores at 30 hours post block initiation. Secondary end points
will include, opioid consumption, time to first analgesic request; pain scores; binary
patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg
raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative
nausea, and vomiting.
Methods and Measures Design The study will be a randomized, double-blind, sham catheter
study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm"
receive a single shot adductor canal block containing 20 milliliters (ml) of solution
including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of
clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in
the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm.
The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in
the current pump in use at our hospital). An opaque bag will be placed over the pump for
blinding purposes. The "Control Arm" will receive an adductor canal catheter through which
they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by
an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will
be placed over the control arm pumps in similar fashion. For all patients, the order in the
electronic medical record will be per research pharmacy protocol. For their primary
anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic
or general anesthetic per the anesthesiologist in the operating room.
block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will
provide comparable (equivalent) analgesic control when compared to an adductor catheter. The
primary end point will be pain scores at 30 hours post block initiation. Secondary end points
will include, opioid consumption, time to first analgesic request; pain scores; binary
patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg
raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative
nausea, and vomiting.
Methods and Measures Design The study will be a randomized, double-blind, sham catheter
study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm"
receive a single shot adductor canal block containing 20 milliliters (ml) of solution
including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of
clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in
the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm.
The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in
the current pump in use at our hospital). An opaque bag will be placed over the pump for
blinding purposes. The "Control Arm" will receive an adductor canal catheter through which
they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by
an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will
be placed over the control arm pumps in similar fashion. For all patients, the order in the
electronic medical record will be per research pharmacy protocol. For their primary
anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic
or general anesthetic per the anesthesiologist in the operating room.
Inclusion Criteria:
Patients will be eligible for inclusion in the study if they are:
- Age of 18 years old or older
- Scheduled to primary unilateral total knee arthroplasty.
- Patients must give written informed consent for anesthesia including continuous
adductor canal block for postoperative analgesia prior to recruitment
Exclusion Criteria:
Patients will be excluded if they have:
- A contraindication to an adductor canal block or catheter placement including, but not
limited to site infection, irritation, or refusal.
- Poorly controlled diabetes (A1C >8.0)
- Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine,
clonidine, or dexamethasone)
- Opioid use >40 mg of oxycodone daily, long-acting opioids.
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