Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915522
• Other study ID #: CEIC-1806
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: September 2, 2019

Study information

• Verified date: April 2019
• Source: Institut de Recerca Biomèdica de Lleida
• Contact: Reis Drudis Morell, MD
• Phone: 34630011138
• Email: reisdrudis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectivity of adductor canal block performed the day after total knee arthroplasty surgery in reducing pain and improving walking ambulation ability and muscle strength.

Description:

Overview: total knee arthroplasty is a painful procedure. According to our institutional pain registers the worst pain appears in postoperative day one, which could be related to the use of effective but short analgesic intraoperative techniques like periarticular local analgesic infiltration and intravenous multimodal analgesia.

The aim: to asses if adductor canal block performed the day after primary total knee arthroplasty (16-20 hours postoperative) improves analgesia without motor blockade and impairment of early ambulation ability.

Primary Hypothesis: adductor canal block performed 16-20 hours after primary total knee arthroplasty improves postoperative analgesia.

Secondary Hypothesis: adductor canal block performed 16-20 hours after primary total knee arthroplasty improves ability of early ambulation, adductor and quadriceps strength after primary total knee arthroplasty.

The objectives:

1. To compare postoperative pain control effects between adductor canal block and placebo block.

2. To assess the improvement of ability of early ambulation and extent of motor blockade after primary total knee joint replacement surgery between the groups of patients.

3. To estimate variations in quadriceps and adductor muscle strength in the two groups of patients.

4. To asses related side effects to adductor canal nerve block.

5. To asses variations in length of stay between the two groups.

Methods:

The prospective, double-blinded study includes American Society of Anesthesiologists (ASA) physical status I-III in preoperative assessment, aged 18-85 years, admitted for primary total knee arthroplasty. Preoperatively a simple randomization is made to distribute the included patients in two groups: Standard Group and Intervention Group. A table of random numbers is used, first selecting the starting point and later the movement direction remains constant throughout the whole table. The even numbers are allocated in the Standard Group and the odd ones in the Intervention group. The anesthesiologist performing the block will be aware of the treatment, but the participant subject and outcomes assessor will be blinded to the group assignment.

During the perioperative period all patients from both groups will receive a standardized anesthetic and analgesic treatment: premedication with midazolam 2.5-5 mg and dexamethasone 0'1 mg/kg, spinal anesthesia with 10mg of hyperbaric bupivacaine and intravenous propofol during the surgery for sedation. As analgesia paracetamol 1gr plus dexketoprofen 50 mg. The local infiltration analgesia will be performed in a protocolized manner during the surgery with ropivacaine 0'2% 120 cc mixed with 0'6 mg adrenaline and at the end of surgery with ropivacaine 0'2% 40cc for subcutaneous infiltration. Two doses of 0'1mg/kg tranexamic acid are administrated unless contraindication, first one 30 min before skin incision and second one three hours later.

Postoperative analgesia will be administrated to both groups of patients with ibuprofen 600 mg/8h and paracetamol 1gr/6h. Opioids will be available to patients as intravenous boluses of tramadol 1mg/kg if pain numerical rate score (NRS) > 3 at rest or > 5 at movement.

All patients included in the study are transferred to post-anesthesia reanimation unit 16-20h after surgery, in postoperative day one. The operated extremity is slightly externally rotated and prepared for the block with 2% chlorhexidine and sterile dressing and the adductor canal is identified with ultrasound image at the mid-thigh level. In standard group patients a sham adductor canal block with 2ml of 1% subcutaneous lidocaine is done. In intervention group patients an adductor canal block with a 22 Gauge ultrasound-visible needle and 20 ml of 0'5% ropivacaine is done. At the end all patients have a sterile apposite on the puncture site.

Postoperative pain will be assessed 15 minutes before the procedure (adductor or sham block), 2 hour, 24 hour post and also in the three nursing rounds (morning, afternoon, night) the first 72 hours after surgery. The pain numeric rating scale (NRS) is used (from 0 - no pain to 10 - worst imaginable pain) at rest and during active knee flexion. The requirement of additional opioids and their side effects (if any) will be recorded.

Knee extensor and adductor muscle strength is measured using a hand-held dynamometer (Baseline Digital Hydraulic Push Pull Dynamometer R)) immediately prior to surgery, in first postoperative, day immediately before the procedure, 2 hours and 24 hour postprocedure.

Patients ability of early ambulation is evaluated using ten meter walk test (TMWT) in the first and second postoperative day every 12h.

The success rate of the block is assessed by testing for sensation of cold and pinprick stimulus at the medial midcalf using a 3-point scale (2 = normal sensation, 1 = decreased sensation, 0 = no sensation) 2 hours after block.

The length of hospital stay and rate of complications (if any), will be recorded in both groups of patients. Complications will be graded as local complications (hematoma, wound complications…), block complications (falls, vascular injection…), urinary complications (acute urine retention, renal failure…) and general complications (neurological, respiratory, cardiological…).

According to study protocol, both groups of patients will be compared in terms of postoperative pain control, opioid consumption, postoperative nausea and vomiting, quadriceps strength, adductor strength, ability of early ambulation, length of hospitalization and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective unilateral total knee arthroplasty

• American Society of Anesthesiologist (ASA) class 1-3

• Adults aged 18-85 years old

Exclusion Criteria:

• Contraindications of the adductor canal block.

• Contraindications of the local infiltration analgesia technique.

• Chronic kidney disease

• Surgery to be performed under general anesthesia.

• Opioid treatment > 30 mgr morphine or equivalent for more than 3 months time.

• Neuropathic ipsilateral pain.

• Inability to understand study procedures.

• Not acceptance of the procedure (adductor canal block or local infiltration analgesia).

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Procedure:
• Single adductor canal block
The operated leg is slightly externally rotated and prepared for a block with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and after a subcutaneous injection of 2 ml of 1% lidocaine a total of 20 ml of 0'5% ropivacaine is injected into the canal using a 22 gauge ultrasound-visible needle. In the end, a sterile apposite is placed at the puncture site
• Simulated adductor canal block
The operated leg is slightly externally rotated and prepared with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and at this leve a subcutaneous injection of 2 ml of 1% lidocaine . After, a sterile apposite is placed at the puncture site.

Locations

Country	Name	City	State
Spain	Hospital Universitary Santa Maria	Lleida

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recerca Biomèdica de Lleida

Country where clinical trial is conducted

Spain, 

References & Publications (19)

Andersen HL, Gyrn J, Møller L, Christensen B, Zaric D. Continuous saphenous nerve block as supplement to single-dose local infiltration analgesia for postoperative pain management after total knee arthroplasty. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):106-11. doi: 10.1097/AAP.0b013e31827900a9. — View Citation

Andersen LØ, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17. Review. — View Citation

Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. — View Citation

Dong CC, Dong SL, He FC. Comparison of Adductor Canal Block and Femoral Nerve Block for Postoperative Pain in Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Mar;95(12):e2983. doi: 10.1097/MD.0000000000002983. Review. — View Citation

Fajardo M, Collins J, Landa J, Adler E, Meere P, Di Cesare PE. Effect of a perioperative intra-articular injection on pain control and early range of motion following bilateral TKA. Orthopedics. 2011 May 18;34(5):354. doi: 10.3928/01477447-20110317-11. — View Citation

Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8. — View Citation

Hanson NA, Allen CJ, Hostetter LS, Nagy R, Derby RE, Slee AE, Arslan A, Auyong DB. Continuous ultrasound-guided adductor canal block for total knee arthroplasty: a randomized, double-blind trial. Anesth Analg. 2014 Jun;118(6):1370-7. doi: 10.1213/ANE.0000000000000197. — View Citation

Hussain N, Ferreri TG, Prusick PJ, Banfield L, Long B, Prusick VR, Bhandari M. Adductor Canal Block Versus Femoral Canal Block for Total Knee Arthroplasty: A Meta-Analysis: What Does the Evidence Suggest? Reg Anesth Pain Med. 2016 May-Jun;41(3):314-20. doi: 10.1097/AAP.0000000000000376. Review. — View Citation

Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26. — View Citation

Jæger P, Koscielniak-Nielsen ZJ, Schrøder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014. — View Citation

Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b. — 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

Kuang MJ, Xu LY, Ma JX, Wang Y, Zhao J, Lu B, Ma XL. Adductor canal block versus continuous femoral nerve block in primary total knee arthroplasty: A meta-analysis. Int J Surg. 2016 Jul;31:17-24. doi: 10.1016/j.ijsu.2016.05.036. Epub 2016 May 19. Review. — View Citation

Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80. — View Citation

Li D, Yang Z, Xie X, Zhao J, Kang P. Adductor canal block provides better performance after total knee arthroplasty compared with femoral nerve block: a systematic review and meta-analysis. Int Orthop. 2016 May;40(5):925-33. doi: 10.1007/s00264-015-2998-x. Epub 2015 Oct 10. Review. — View Citation

Ma J, Gao F, Sun W, Guo W, Li Z, Wang W. Combined adductor canal block with periarticular infiltration versus periarticular infiltration for analgesia after total knee arthroplasty. Medicine (Baltimore). 2016 Dec;95(52):e5701. doi: 10.1097/MD.0000000000005701. — View Citation

Sawhney M, Mehdian H, Kashin B, Ip G, Bent M, Choy J, McPherson M, Bowry R. Pain After Unilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial Examining the Analgesic Effectiveness of a Combined Adductor Canal Peripheral Nerve Block with Periarticular Infiltration Versus Adductor Canal Nerve Block Alone Versus Periarticular Infiltration Alone. Anesth Analg. 2016 Jun;122(6):2040-6. doi: 10.1213/ANE.0000000000001210. — View Citation

Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11. Review. — View Citation

Xu CP, Li X, Wang ZZ, Song JQ, Yu B. Efficacy and safety of single-dose local infiltration of analgesia in total knee arthroplasty: a meta-analysis of randomized controlled trials. Knee. 2014 Jun;21(3):636-46. doi: 10.1016/j.knee.2014.02.024. Epub 2014 Mar 13. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale	Assessed using a Numerical Rating Scale (NRS) from 0 to 10	Registered immediately prior to surgery, first postoperative day immediately prior to procedure, 2 hours postprocedure and every 8 hours the first three days in the orthopedic ward.
Secondary	Knee extensor muscle strength	Measured using a hand-held dynamometer	Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Secondary	Adductor muscle strength	Measured using a hand-held dynamometer	Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Secondary	Ability to walk with ten meter walk test	Measured with the ten meter walk test (TMWT)	First and second postoperative day every 12 hours
Secondary	Rate of pain rescue treatments.	Rate of intravenous opioid needed by the patients.	First 72 hours following surgery
Secondary	Rate of opioid side effects.	Rate of episodes of dizziness or nausea or vomit after opioid intake.	First 72 hours following surgery
Secondary	Length of hospital stay		From date to operation until the data of discharge home, assessed up to 1 month
Secondary	Rate of adductor canal block complications	Including: local swelling, hematoma, vascular or neurological lesion and falls.	First 72 hours following surgery
Secondary	Rate of surgery local complications	Including, hematoma, wound infection, arthroplasty infection, vascular or neurological lesion.	From date to operation until the data of discharge home, assessed up to 1 month
Secondary	Rate of medical complications	Including neurological, cardiological, urological and respiratory.	From date to operation until the data of discharge home, assessed up to 1 month