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

Postoperative Pain Clinical Trial

— PIPACK  

Official title:

Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Undergoing Total Knee Arthroplasty Under Spinal Anesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179641
• Other study ID #: CER-VD 2023-02041
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: July 18, 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Marta Szyszko du Bois d'Aische
• Phone: +41795564002
• Email: marta.szyszko[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this randomized controlled double blinded trail is to compare an analgesic effect of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block vs selective tibial nerve block in patients scheduled for total knee arthroplasty under spinal anesthesia with an adductor canal block.

The investigators presume that association of a selective tibial nerve block with an adductor canal block provides better postoperative analgesia than a combination of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block with an adductor canal block. The research team plan on including 100 patients and randomly assign them to two groups of 50 patients each. After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization. All patients will receive central spinal anesthesia with 12.5 mg of hyperbaric bupivacaine with 100 mcg of morphine and an adductor canal block with 150 mg of ropivacaine. IPACK block group will then receive an IPACK block with 38 mg of ropivacaine and a tibial nerve group will receive a selective tibial nerve block with 37.5 mg of ropivacaine.

During the surgery, iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg. will be administered to all patients.

After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.

The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain related outcomes are cumulative morphine consumption in the recovery room, at day 1, day 2 and day 3 postoperatively, rest and dynamic pain scores, duration of peripheral nerve block defined as the time between the execution of the block and the first dose of iv morphine, incidence of postoperative nausea and vomiting and pruritus during 3 days following surgical intervention, incidence of peroneal nerve block and complications of peripheral nerve blocks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 18, 2025
• Est. primary completion date: July 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists classification I-III

• 18 yo or older

• patients scheduled for total knee arthroplasty under central spinal anesthesia

• informed consent signed

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Analgesia
• Arthropathy of Knee
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Selective tibial nerve block
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.
• IPACK block
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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total iv morphine consumption	consumption in mg	24 hours postoperatively
Secondary	Morphine consumption in the recovery room	consumption in mg	From admission till discharge from the recovery room, up to 2 hours
Secondary	PCA administered morphine consumption	consumption in mg administered by PCA	at day 1, day 2 and day 3 postoperatively
Secondary	rest and dynamic pain scores	Visual Analogue scale(VAS), 0-10 where 0 is no pain and 10 is the worst pain imaginable	at day 1, day 2 and day 3 postoperatively
Secondary	Duration of peripheral nerve block	Time between execution of a peripheral nerve block and the first dose of iv morphine	From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours
Secondary	Incidence of postoperative nausea and vomiting	Presence of nausea and vomiting in the postoperative period	at day 1, day 2 and day 3 postoperatively
Secondary	Incidence of pruritus	Presence of pruritus	at day 1, day 2 and day 3 postoperatively
Secondary	peroneal nerve block	presence of peroneal nerve block	at day 1, day 2 and day 3 postoperatively
Secondary	complications of peripheral nerve blocks	iv injection, hematoma, infection	at the moment of execution of the block (day 0) and at day 3 postoperatively
Secondary	passive and active motion range	joint motion in degrees	at day 3 postoperatively
Secondary	quadriceps strength	Percentage of strength as compared with the opposite leg	at day 3 postoperatively
Secondary	walking distance	walking distance without pain	at 72h postoperatively
Secondary	hospital stay	length of hospital stay in days	from admission to the hospital till discharge, up to 3 days