Comparison of Two Different Regional Analgesia Techniques for Patients Undergoing Total Knee Arthroplasty

NCT06179641 | Recruiting DMC

• 1 other identifier: CER-VD 2023-02041
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to compare two regional analgesia techniques in patients undergoing total knee arthroplasty: IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) vs selective tibial nerve block. The main question is whether one of these peripheral blocks is more effective in reducing postoperative pain than the other. All patients will have a spinal block with an adductor canal block. One group will receive an IPACK block and the other group, a selective tibial nerve block. Postoperative pain scores and morphine consumption, among others, will be compared between groups.

Conditions

Analgesia; Arthropathy of Knee; Postoperative Pain

Keywords

nerve block; pain management; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total iv morphine consumption

  consumption in mg

  24 hours postoperatively

Secondary Outcomes (12)

• Morphine consumption in the recovery room

  From admission till discharge from the recovery room, up to 2 hours

• PCA administered morphine consumption

  at day 1, day 2 and day 3 postoperatively

• rest and dynamic pain scores

  at day 1, day 2 and day 3 postoperatively

• Duration of peripheral nerve block

  From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours

• Incidence of postoperative nausea and vomiting

  at day 1, day 2 and day 3 postoperatively

Study Arms (2)

IPACK group

ACTIVE COMPARATOR

IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block

Procedure: IPACK block

Tibial nerve group

EXPERIMENTAL

selective tibial nerve block

Procedure: Selective tibial nerve block

Interventions

Selective tibial nerve block PROCEDURE

The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anesthetics around the nerve.

Tibial nerve group

IPACK block PROCEDURE

The IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where nineteen mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anesthetics will be observed above the posterior capsule.

IPACK group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists classification I-III
• yo or older
• patients scheduled for total knee arthroplasty under central spinal anesthesia
• informed consent signed

You may not qualify if:

• Refusal or inability for informed consent
• Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
• Secondary surgical revision
• Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
• Bleeding diathesis
• Neurological deficit
• Known renal insufficiency (eGFR \<45 ml/min)
• Known hepatic insufficiency (Child score B or C)
• Alcohol abuse

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (8)

• Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.

  PMID: 9661552 BACKGROUND

• Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.

  PMID: 20798443 BACKGROUND

• Williams DP, O'Brien S, Doran E, Price AJ, Beard DJ, Murray DW, Beverland DE. Early postoperative predictors of satisfaction following total knee arthroplasty. Knee. 2013 Dec;20(6):442-6. doi: 10.1016/j.knee.2013.05.011. Epub 2013 Jun 16.

  PMID: 23777807 BACKGROUND

• Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.

  PMID: 19844772 BACKGROUND

• van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.

  PMID: 8403121 BACKGROUND

• Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.

  PMID: 18627367 BACKGROUND

• Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.

  PMID: 28260964 BACKGROUND

• Paulou F, Wegrzyn J, Rossel JB, Gonvers E, Antoniadis A, Kagi M, Wolmarans MR, Lambert J, Albrecht E. Analgesic efficacy of selective tibial nerve block versus partial local infiltration analgesia for posterior pain after total knee arthroplasty: a randomized, controlled, triple-blinded trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101223. doi: 10.1016/j.accpm.2023.101223. Epub 2023 Apr 6.

  PMID: 37030393 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Central Study Contacts

Marta Szyszko du Bois d'Aische

CONTACT

+41795564002; marta.szyszko@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Med. Eric Albrecht

Model Details: single centered, prospective, randomized double blinded controlled trial

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 22, 2023
• Study Start: February 8, 2024
• Primary Completion: July 12, 2025
• Study Completion: July 18, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CH (1)