Adductor Canal Block for Medial Compartment Knee Arthroplasty

Postoperative Analgesia Clinical Trial

Official title:

Evaluation of Ultrasound-Guided Adductor Canal Blockade for Postoperative Analgesia Following Robotic Medial Unicompartmental Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818531
• Other study ID #: IRB00023002
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the affects of a single injection ultrasound-guided adductor canal block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia provided by the adductor canal block with that provided by single injection lumbar plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal block will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome will be a comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-85

• Undergoing unilateral robotic-assisted (MAKOplasty) medial compartment knee arthroplasty at Wake Forest University Baptist Medical Center.

• Must give written informed consent for anesthesia including subarachnoid blockade and peripheral nerve blockade of both the lumbar plexus and adductor canal.

• Must consent to the performance of a sham block at the site to which they are not randomized.

• Must also be reliable to give accurate verbal pain scores postoperatively.

Exclusion Criteria:

• Contraindication to adductor canal blockade or lumbar plexus blockade (including significant coagulation abnormalities)

• History of opioid addiction or current chronic pain therapy for pain other than at the surgical site that is being treated with high-dose opioids (extended release opioids or > 40mg oxycodone equivalents per day)

• Allergy to study medications

• Failure to adequately place either the adductor canal or lumbar plexus blocks.

• Patients who decline or have a contraindication to subarachnoid blockade will also be excluded from the study.

• Pregnancy.

Related Conditions & MeSH terms

• Medial Unicompartmental Knee Arthroplasty
• Postoperative Analgesia

Intervention

Drug:
• Adductor canal block

• Lumbar plexus block

Locations

Country	Name	City	State
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (10)

Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. — View Citation

Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. — View Citation

GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. — View Citation

Horner G, Dellon AL. Innervation of the human knee joint and implications for surgery. Clin Orthop Relat Res. 1994 Apr;(301):221-6. — View Citation

Jenstrup MT, Jæger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4. — View Citation

Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. — View Citation

Lund J, Jenstrup MT, Jaeger P, Sørensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29. — View Citation

Meek RM, Masri BA, Duncan CP. Minimally invasive unicompartmental knee replacement: rationale and correct indications. Orthop Clin North Am. 2004 Apr;35(2):191-200. Review. — View Citation

Riddle DL, Jiranek WA, McGlynn FJ. Yearly incidence of unicompartmental knee arthroplasty in the United States. J Arthroplasty. 2008 Apr;23(3):408-12. doi: 10.1016/j.arth.2007.04.012. Epub 2007 Nov 26. — View Citation

Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Pain Scores at 6 Hours Post Nerve Blockade.	Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes.	6 hours post block.
Secondary	Opioid Consumption	Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.	6, 12, 18, and 24 hours
Secondary	Time to First Analgesic	Time to first analgesic between two groups: adductor canal block and lumbar plexus block.	24 hours
Secondary	Opioid Related Side Effects	Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block.	6, 12, 18, and 24 hours
Secondary	Quadriceps Motor Strength	Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes.	6 hours