Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?

Pain Management Clinical Trial

Official title:

Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02276495
• Other study ID #: 20141217
• Secondary ID: UCIANES06
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2014
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of a single injection adductor canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).

Description:

Total knee arthroplasty (TKA), also known as total knee replacement, has been associated with a significant pain burden in the postoperative period. Methods to manage pain associated with this operation have in the past included injecting pain medication into the epidural space of the spinal cord, around a peripheral nerve, around the space surrounding the joint, or a combination of pain management techniques. In recent years, the femoral nerve block (injection of pain medication around the peripheral nerve, specifically the femoral nerve) has been proposed as an effective way to manage pain while sparing many of the undesirable side effects of narcotic pain medications. Traditional techniques of the femoral nerve block involve the injection of pain medication around the peripheral nerve at the level of the groin area. A nerve block at this point in the path of the femoral nerve affects all of the musculature of the front part of the thigh as well as the nerves responsible for sensation to the majority of the knee joint. The femoral nerve block performed at the level of the groin provides an excellent level of pain relief at the knee joint, but is also associated with weakness of the quadriceps muscle. The resultant quadriceps weakness can both slow the physical therapy process and be a risk factor for post-operative falls. Participation in physical therapy is a critical component of the rehabilitation process and is started as soon as tolerated by the patient. The ideal pain management technique would provide the same degree of pain relief as the femoral nerve block while preserving the strength in the front part of the thigh muscles. One suggested technique to achieve both of these goals is the injection of a large volume dilute local pain medication mixture around the joint during surgery. This has been used as a substitute to provide pain relief around the joint while maintaining strength in the quadriceps muscle and the ability to participate in physical therapy. This technique however, does not last long since the medication disperses away from the joint space. A variation of the femoral nerve block in the lower thigh, within a space called the adductor canal, has been demonstrated to provide equivalent amounts of pain relief as a proximal femoral nerve block along with preservation of motor function to the quadriceps muscle. What is not as well-established is whether the combination of injecting pain medication directly around the joint space in the knee along with a single injection of pain medication in the adductor canal in the lower thigh can improve pain scores and extend the duration of pain relief provided compared to only an injection around the joint space.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: June 30, 2024
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and Females age 18+ years old having total knee arthroplasty (TKA) at UCI Medical Center
• American Society of Anesthesiologists physical status I to III

Exclusion Criteria:

• Allergy to local anesthetics
• Pregnancy
• Nursing Mothers
• Children <18 years of age
• Renal impairment (GFR<60 mL/min/1.73m2)
• Hepatic Impairment (active hepatitis, elevated AST or ALT, jaundice)
• Opioid tolerant patients (defined as greater than 30 mg Morphine equivalent consumed daily)
• Patients that are diabetic with peripheral neuropathy
• BMI greater than 40

Related Conditions & MeSH terms

• Pain Management

Intervention

Other:
• ACB Control - 20 ml saline injection for ACB
Adductor Canal Block Control (20 ml saline injection)

Drug:
• ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
• Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (10)

Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a. — View Citation

Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24. — View Citation

Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015. — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. — View Citation

Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y. — View Citation

Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8. — View Citation

Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18. — View Citation

Robbins SM, Rastogi R, McLaughlin TL. Predicting acute recovery of physical function following total knee joint arthroplasty. J Arthroplasty. 2014 Feb;29(2):299-303. doi: 10.1016/j.arth.2013.06.033. Epub 2013 Jul 26. — View Citation

Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20. — View Citation

Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	The primary outcome variable of interest is the average maximum pain score within 24 hours postoperative.	within 24 hours postoperative
Secondary	Opioid Use	24 Hour post-surgical opioid use	within 24 hours postoperative
Secondary	PACU Opioid Use	PACU opioid use	Postoperative (while in PACU), an expected average of 60 minutes
Secondary	Daily Opioid Use	Average daily opioid use during hospitalization	duration of hospital stay, an expected average of 3 days
Secondary	Average NRS Pain Score	Average NRS pain score	within 24 hours postoperative
Secondary	Length of Stay	Length of hospital stay	duration of hospital stay, an expected average of 3 days