Transdermal Fentanyl as a Form of Rebound Pain Reduction in Fast Track Programme in Primary Knee Arthroplasty.

NCT06431906 | Not Yet Recruiting

• 1 other identifier: FEN
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total knee arthroplasty is a common surgery in routine clinical practice that, although it achieves an improvement in the functionality and quality of life of patients, it causes intense postoperative pain. In this regard, locoregional block techniques are commonly used for the immediate postoperative period. However, these techniques have the disadvantage of being of limited duration and the appearance of so-called "rebound pain" when their effect wears off. To counteract this problem and maintain adequate analgesic control over a longer period of time, the use of a transdermal fentanyl patch seems to be a good option, with advantages over the traditional approach of placing a morphine PCA. Specifically, the aims of the study are: the evaluation of the decrease in the rate of rebound pain after locoregional techniques using a transdermal fentanyl patch after primary knee arthroplasty, as well as the evaluation of non-inferiority in terms of functional recovery, analgesic efficacy and adverse effects compared to morphine PCA. Methods: This will be a prospective observational cohort study, with a total N of 106 patients undergoing total knee arthroplasty who meet the study inclusion criteria. The numerical pain rating scale score will be collected at 6,8,12,24 and 26h from which the "rebound pain score" will be calculated. The need for pharmacological rescue will be assessed as well as the appearance of adverse effects at 12, 24 and 36h and finally the QoR15 scale will be assessed at 36h.

Conditions

Postoperative Pain

Keywords

fentanyl; morphine PCA; rebound pain

Outcome Measures

Primary Outcomes (1)

• - Responders to the decrease in the rate of "rebound pain" with the use of transdermal fentanyl patch relative to morphine PCA:

  \- Rebound pain score (RPS): Defined as the result of subtracting the minimum score on the pain scale the first 12 hours before the end of action of the peripheral blockade from the maximum score on the pain scale the first 12 hours after the disappearance of the action of the peripheral blockade. To calculate this variable, the numerical pain scale score will be collected 6, 8, 12, 24 and 36 hours after the peripheral nerve block.

  6,8,12,24 and 36hours after the lock

Secondary Outcomes (3)

• non-inferiority of PFT vs PCA morphine in terms of early postoperative recovery:

  48 hours in the postoperative period

• non-inferiority of PFT vs. morphine PCA in terms of post-surgical analgesia:

  48 hours in the postoperative period

• non-inferiority of PFT vs morphine PCA in terms of adverse effects:

  48 hours in the postoperative period

Study Arms (2)

transdermal fentanyl

Subjects receiving a transdermal fentanyl patch for postoperative pain control will be included here.

morphine PCA

Subjects receiving a morphine PCA for postoperative pain control will be included here.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy.

You may qualify if:

• All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy

You may not qualify if:

• Prior opioid treatment.
• History of previous opioid adverse effects.
• History of PONV.
• History of medical history that conditions baseline alteration of the data to be collected.
• Contraindication to neuroaxial techniques.
• Difficulty in understanding the scales used.
• Patient's refusal.

Sponsors & Collaborators

• Oscar Diaz-Cambronero: lead

Related Publications (28)

• Sathitkarnmanee T, Tribuddharat S, Noiphitak K, Theerapongpakdee S, Pongjanyakul S, Huntula Y, Thananun M. Transdermal fentanyl patch for postoperative analgesia in total knee arthroplasty: a randomized double-blind controlled trial. J Pain Res. 2014 Aug 1;7:449-54. doi: 10.2147/JPR.S66741. eCollection 2014.

  PMID: 25120375 BACKGROUND

• Matsumoto S, Matsumoto K, Iida H. Transdermal fentanyl patch improves post-operative pain relief and promotes early functional recovery in patients undergoing primary total knee arthroplasty: a prospective, randomised, controlled trial. Arch Orthop Trauma Surg. 2015 Sep;135(9):1291-7. doi: 10.1007/s00402-015-2265-z. Epub 2015 Jun 26.

  PMID: 26112273 BACKGROUND

• Hall MJ, Dixon SM, Bracey M, MacIntyre P, Powell RJ, Toms AD. A randomized controlled trial of postoperative analgesia following total knee replacement: transdermal Fentanyl patches versus patient controlled analgesia (PCA). Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1073-9. doi: 10.1007/s00590-015-1621-6. Epub 2015 Mar 11.

  PMID: 25753087 BACKGROUND

• Kehlet H, Thienpont E. Fast-track knee arthroplasty -- status and future challenges. Knee. 2013 Sep;20 Suppl 1:S29-33. doi: 10.1016/S0968-0160(13)70006-1.

  PMID: 24034592 BACKGROUND

• Lindberg-Larsen M, Petersen PB, Corap Y, Gromov K, Jorgensen CC, Kehlet H; Centre for Fast-track Hip and Knee Replacement Collaborating Group. Fast-track revision hip arthroplasty: a multicenter cohort study on 1,345 elective aseptic major component revision hip arthroplasties. Acta Orthop. 2022 Feb 23;93:341-347. doi: 10.2340/17453674.2022.2196.

  PMID: 35195270 BACKGROUND

• Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.

  PMID: 29721648 BACKGROUND

• Abdullah MA, Abu Elyazed MM, Mostafa SF. The Interspace Between Popliteal Artery and Posterior Capsule of the Knee (IPACK) Block in Knee Arthroplasty: A Prospective Randomized Trial. Pain Physician. 2022 May;25(3):E427-E433.

  PMID: 35652772 BACKGROUND

• Tang X, Jiang X, Lei L, Zhu W, Fu Z, Wang D, Chen J, Ning N, Zhou Z. IPACK (Interspace between the Popliteal Artery and the Capsule of the Posterior Knee) Block Combined with SACB (Single Adductor Canal Block) Versus SACB for Analgesia after Total Knee Arthroplasty. Orthop Surg. 2022 Nov;14(11):2809-2821. doi: 10.1111/os.13263. Epub 2022 Sep 20.

  PMID: 36125191 BACKGROUND

• Ochroch J, Qi V, Badiola I, Grosh T, Cai L, Graff V, Nelson C, Israelite C, Elkassabany NM. Analgesic efficacy of adding the IPACK block to a multimodal analgesia protocol for primary total knee arthroplasty. Reg Anesth Pain Med. 2020 Oct;45(10):799-804. doi: 10.1136/rapm-2020-101558. Epub 2020 Aug 31.

  PMID: 32868483 BACKGROUND

• Kampitak W, Tanavalee A, Ngarmukos S, Tantavisut S. Motor-sparing effect of iPACK (interspace between the popliteal artery and capsule of the posterior knee) block versus tibial nerve block after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):267-276. doi: 10.1136/rapm-2019-100895. Epub 2020 Feb 4.

  PMID: 32024676 BACKGROUND

• Guo J, Hou M, Shi G, Bai N, Huo M. iPACK block (local anesthetic infiltration of the interspace between the popliteal artery and the posterior knee capsule) added to the adductor canal blocks versus the adductor canal blocks in the pain management after total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2022 Aug 12;17(1):387. doi: 10.1186/s13018-022-03272-5.

  PMID: 35962410 BACKGROUND

• Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.

  PMID: 33915199 BACKGROUND

• Nobre LV, Cunha GP, Sousa PCCB, Takeda A, Cunha Ferraro LH. [Peripheral nerve block and rebound pain: literature review]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):587-593. doi: 10.1016/j.bjan.2019.05.001. Epub 2019 Nov 2.

  PMID: 31690509 BACKGROUND

• Admassie BM, Tegegne BA, Alemu WM, Getahun AB. Magnitude and severity of rebound pain after resolution of peripheral nerve block and associated factors among patients undergoes surgery at university of gondar comprehensive specialized hospital northwest, Ethiopia, 2022. Longitudinal cross-sectional study. Ann Med Surg (Lond). 2022 Nov 18;84:104915. doi: 10.1016/j.amsu.2022.104915. eCollection 2022 Dec.

  PMID: 36536717 BACKGROUND

• Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.

  PMID: 30124544 BACKGROUND

• Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.

  PMID: 17543812 BACKGROUND

• Munoz-Leyva F, Cubillos J, Chin KJ. Managing rebound pain after regional anesthesia. Korean J Anesthesiol. 2020 Oct;73(5):372-383. doi: 10.4097/kja.20436. Epub 2020 Aug 10.

  PMID: 32773724 BACKGROUND

• Hade AD, Okano S, Pelecanos A, Chin A. Factors associated with low levels of patient satisfaction following peripheral nerve block. Anaesth Intensive Care. 2021 Mar;49(2):125-132. doi: 10.1177/0310057X20972404. Epub 2021 Mar 30.

  PMID: 33784851 BACKGROUND

• Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257.

  PMID: 31491863 BACKGROUND

• Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.

  PMID: 33390261 BACKGROUND

• Fang J, Shi Y, Du F, Xue Z, Cang J, Miao C, Zhang X. The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 12;21(1):47. doi: 10.1186/s12871-021-01267-z.

  PMID: 33579199 BACKGROUND

• Abrisham SM, Ghahramani R, Heiranizadeh N, Kermani-Alghoraishi M, Ayatollahi V, Pahlavanhosseini H. Reduced morphine consumption and pain severity with transdermal fentanyl patches following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Jul;22(7):1580-4. doi: 10.1007/s00167-012-2287-9. Epub 2012 Dec 2.

  PMID: 23212185 BACKGROUND

• van Bastelaere M, Rolly G, Abdullah NM. Postoperative analgesia and plasma levels after transdermal fentanyl for orthopedic surgery: double-blind comparison with placebo. J Clin Anesth. 1995 Feb;7(1):26-30. doi: 10.1016/0952-8180(94)00000-t.

  PMID: 7772354 BACKGROUND

• Minville V, Lubrano V, Bounes V, Pianezza A, Rabinowitz A, Gris C, Samii K, Fourcade O. Postoperative analgesia after total hip arthroplasty: patient-controlled analgesia versus transdermal fentanyl patch. J Clin Anesth. 2008 Jun;20(4):280-3. doi: 10.1016/j.jclinane.2007.12.013.

  PMID: 18617126 BACKGROUND

• Nelson L, Schwaner R. Transdermal fentanyl: pharmacology and toxicology. J Med Toxicol. 2009 Dec;5(4):230-41. doi: 10.1007/BF03178274.

  PMID: 19876859 BACKGROUND

• Grond S, Radbruch L, Lehmann KA. Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl. Clin Pharmacokinet. 2000 Jan;38(1):59-89. doi: 10.2165/00003088-200038010-00004.

  PMID: 10668859 BACKGROUND

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

  PMID: 29397134 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Beatriz García Rivas

CONTACT

636054510; beatrizgr97@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MÉDICO ADJUNTO ANESTESIOLOGÍA

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 29, 2024
• Study Start: August 1, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share