- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05807945
"Comparison of Intra-articular of 2% Ropivacaine vs. 7.5% Ropivacaine in Postoperative of Knee Arthroscopy" (ropivacaine)
Comparison of the Effect of Intra-articular Administration of 2% Ropivacaine vs. 7.5% Ropivacaine as an Analgesic in the Immediate Postoperative Period of Knee Arthroscopy in Acute Injuries at the ABC Medical Center
All patients with acute lesions that attend the orthopedic and trauma center of the ABC medical center are invited to participate in the study. Those that meet the inclusion criteria and later sign an informed consent are randomized to receive 10 ml of a solution with ropivacaine at 7.5% and 2.0% intraarticular for the first 5 minutes after the end of surgery (closing of surgical wounds). Both the patient, the physician who applies it and the evaluator of outcomes remain blinded to the dose of ropivacaine the patient receives.
Two hours after the end of the surgery, while the patient is in his room, the presence of pain is evaluated by a visual analog scale (VAS), while the patient is asked to flex and extend his knee. The result is quantified continuously, to later categorize the pain in none to slight pain (0-3 points) and moderate-severe pain (4-10 points). All the information is recorded on established forms in the clinical file (general data), that includes the variables of interest for the study, and is reported by the physicians after standardization of all those in charge with collecting information to comply with the conceptual and operative operationalization of the variables described in the research protocol. In addition to the evaluation of pain, the administration of opioids to patients for necessary reasons (presence of pain) by the physicians in charge is recorded.
It is hoped that, in patients with knee arthroscopy for acute lesion, there is a difference in the frequency of moderate-severe pain of 30% in the post-operative (frequency of 37.5% in patients with ropivacaine at 2% and frequency of 7.5% in patients with ropivacaine at 7.5%).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In previous studies the prevalence of moderate-severe intensity pain in patients post knee arthroscopy is 71.2%, and the prevalence of acute pain in post-operative is 37.5%, surpassing the prevalence when compared with other surgical procedures of various specialties.
The administration of opioids is part of common practice in managing pain. However, it represents a risk for patients due to adverse effects and the high risk of dependence. It is necessary to seek alternatives that reduce the consumption of opioids in patients post knee arthroscopy.
Characteristics of the patients reported in other studies, such as sex, body mass index, sedentarism, the cause, duration and use of tourniquet in surgery, in addition to the type of lesion of articular cartilage and the presence of neuropathies, may influence in the presence of pain severity.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Cuajimalpa
-
Mexico City, Cuajimalpa, Mexico, 05300
- American British Cowdray Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mental health: healthy (not taking any medication)
- Articular cartilage lesion Grade I, II or III by Outerbridge
- Elective knee surgery
- Patients with any of the following diagnoses:
- Simple meniscal lesion
- Lesion of a single knee (unilateral)
Exclusion Criteria:
- Neuromotor diseases (alterations in step, strength or sensitivity)
- History of knee surgery (orthopedic)
- Instability that includes knee ligament lesions
- Addictions
- Mental diseases in medical treatment
- Hepatic diseases
- Allergy to any of the medications used in the study
- Epidural or peridural anesthesia
- Chronic pain in treatment
- Postoperative drain of knee arthroscopy
- Pregnant or lactating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ropivacaine 7.5% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 7.5%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 7.5%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
Active Comparator: Ropivacaine 2% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Acute Pain (Visual analogue scale)
Time Frame: 2 hours postoperative
|
The result is quantified continuously in a scale from 0 (No pain) to 10 (Worst pain imaginable) points.
Acute pain is labeled of a value ≥4 points.
|
2 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Opioid administration
Time Frame: 2 hours postoperative
|
The administration of opioids in the first two hours of postoperative for necessary reasons (pain ≥4 points) is recorded by the physician in charge.
|
2 hours postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
- Ng HP, Nordstrom U, Axelsson K, Perniola AD, Gustav E, Ryttberg L, Gupta A. Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):26-33. doi: 10.1016/j.rapm.2005.09.009.
- Casati A, Santorsola R, Aldegheri G, Ravasi F, Fanelli G, Berti M, Fraschini G, Torri G. Intraoperative epidural anesthesia and postoperative analgesia with levobupivacaine for major orthopedic surgery: a double-blind, randomized comparison of racemic bupivacaine and ropivacaine. J Clin Anesth. 2003 Mar;15(2):126-31. doi: 10.1016/s0952-8180(02)00513-5.
- Sun XL, Zhao ZH, Ma JX, Li FB, Li YJ, Meng XM, Ma XL. Continuous Local Infiltration Analgesia for Pain Control After Total Knee Arthroplasty: A Meta-analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Nov;94(45):e2005. doi: 10.1097/MD.0000000000002005.
- Schulze E, Westphal AH, Veenhuis M, de Kok A. Purification and cellular localization of wild type and mutated dihydrolipoyltransacetylases from Azotobacter vinelandii and Escherichia coli expressed in E. coli. Biochim Biophys Acta. 1992 Mar 27;1120(1):87-96. doi: 10.1016/0167-4838(92)90428-g.
- Brattwall M, Jacobson E, Forssblad M, Jakobsson J. Knee arthroscopy routines and practice. Knee Surg Sports Traumatol Arthrosc. 2010 Dec;18(12):1656-60. doi: 10.1007/s00167-010-1266-2. Epub 2010 Sep 21.
- Kim S, Bosque J, Meehan JP, Jamali A, Marder R. Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006. J Bone Joint Surg Am. 2011 Jun 1;93(11):994-1000. doi: 10.2106/JBJS.I.01618.
- Hoofwijk DMN, Fiddelers AAA, Emans PJ, Joosten EA, Gramke HF, Marcus MAE, Buhre WFFA. Prevalence and Predictive Factors of Chronic Postsurgical Pain and Global Surgical Recovery 1 Year After Outpatient Knee Arthroscopy: A Prospective Cohort Study. Medicine (Baltimore). 2015 Nov;94(45):e2017. doi: 10.1097/MD.0000000000002017.
- Tepolt FA, Bido J, Burgess S, Micheli LJ, Kocher MS. Opioid Overprescription After Knee Arthroscopy and Related Surgery in Adolescents and Young Adults. Arthroscopy. 2018 Dec;34(12):3236-3243. doi: 10.1016/j.arthro.2018.07.021. Epub 2018 Nov 2.
- Kanai A, Osawa S, Suzuki A, Ozawa A, Okamoto H, Hoka S. Regression of sensory and motor blockade, and analgesia during continuous epidural infusion of ropivacaine and fentanyl in comparison with other local anesthetics. Pain Med. 2007 Oct-Nov;8(7):546-53. doi: 10.1111/j.1526-4637.2006.00174.x.
- Chew HF, Evans NA, Stanish WD. Patient-controlled bupivacaine infusion into the infrapatellar fat pad after anterior cruciate ligament reconstruction. Arthroscopy. 2003 May-Jun;19(5):500-5. doi: 10.1053/jars.2003.50110.
- Okoroha KR, Keller RA, Marshall NE, Jung EK, Mehran N, Owashi E, Moutzouros V. Liposomal Bupivacaine Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial. Arthroscopy. 2016 Sep;32(9):1838-45. doi: 10.1016/j.arthro.2016.05.033. Epub 2016 Jun 24.
- Daniels SD, Garvey KD, Collins JE, Matzkin EG. Patient Satisfaction With Nonopioid Pain Management Following Arthroscopic Partial Meniscectomy and/or Chondroplasty. Arthroscopy. 2019 Jun;35(6):1641-1647. doi: 10.1016/j.arthro.2019.03.028. Epub 2019 May 6.
- Ozdemir N, Kaya FN, Gurbet A, Yilmazlar A, Demirag B, Mandiraci BO. Comparison of intraarticular bupivacaine and levobupivacaine with morphine and epinephrine for knee arthroscopy. Eurasian J Med. 2013 Jun;45(2):77-82. doi: 10.5152/eajm.2013.18.
- Kaeding CC, Hill JA, Katz J, Benson L. Bupivacaine use after knee arthroscopy: pharmacokinetics and pain control study. Arthroscopy. 1990;6(1):33-9. doi: 10.1016/0749-8063(90)90094-t.
- 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.
- Jacobson E, Forssblad M, Rosenberg J, Westman L, Weidenhielm L. Can local anesthesia be recommended for routine use in elective knee arthroscopy? A comparison between local, spinal, and general anesthesia. Arthroscopy. 2000 Mar;16(2):183-90. doi: 10.1016/s0749-8063(00)90034-3.
- Zou Z, An MM, Xie Q, Chen XY, Zhang H, Liu GJ, Shi XY. Single dose intra-articular morphine for pain control after knee arthroscopy. Cochrane Database Syst Rev. 2016 May 3;2016(5):CD008918. doi: 10.1002/14651858.CD008918.pub2.
- Merivirta R, Aarimaa V, Aantaa R, Koivisto M, Leino K, Liukas A, Kuusniemi K. Postoperative fentanyl patch versus subacromial bupivacaine infusion in arthroscopic shoulder surgery. Arthroscopy. 2013 Jul;29(7):1129-34. doi: 10.1016/j.arthro.2013.04.018.
- Boden BP, Fassler S, Cooper S, Marchetto PA, Moyer RA. Analgesic effect of intraarticular morphine, bupivacaine, and morphine/bupivacaine after arthroscopic knee surgery. Arthroscopy. 1994 Feb;10(1):104-7. doi: 10.1016/s0749-8063(05)80301-9.
- Zhou Y, Yang TB, Wei J, Zeng C, Li H, Yang T, Lei GH. Single-dose intra-articular ropivacaine after arthroscopic knee surgery decreases post-operative pain without increasing side effects: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1651-9. doi: 10.1007/s00167-015-3656-y. Epub 2015 Jun 7.
- Geutjens G, Hambidge JE. Analgesic effects of intraarticular bupivacaine after day-case arthroscopy. Arthroscopy. 1994 Jun;10(3):299-300. doi: 10.1016/s0749-8063(05)80116-1.
- Panigrahi R, Roy R, Mahapatra AK, Prasad A, Priyadarshi A, Palo N. Intra-articular Adjuvant Analgesics following Knee Arthroscopy: Comparison between Single and Double Dose Dexmedetomidine and Ropivacaine A Multicenter Prospective Double-blind Trial. Orthop Surg. 2015 Aug;7(3):250-5. doi: 10.1111/os.12182.
- Sorensen TS, Sorensen AI, Strange K. The effect of intra-articular instillation of bupivacaine on postarthroscopic morbidity: a placebo-controlled, double-blind trial. Arthroscopy. 1991;7(4):364-7. doi: 10.1016/0749-8063(91)90005-i.
- El Baz MM, Farahat TEM. Efficacy of Adding Dexmedetomidine to Intra-articular Levobupivacaine on Postoperative Pain after Knee Arthroscopy. Anesth Essays Res. 2019 Apr-Jun;13(2):254-258. doi: 10.4103/aer.AER_23_19.
- Rokhtabnak F, Ale Bouyeh MR, Seyed Siamdust A, Masoomshahi M, Aghajani M. Comparison of the effects of intra-articular sole ropivacaine and combined ketorolac and ropivacaine for pain control after knee arthroscopy surgery. Br J Pain. 2015 Aug;9(3):149-56. doi: 10.1177/2049463714553312.
- Mitra S, Kaushal H, Gupta RK. Evaluation of analgesic efficacy of intra-articular bupivacaine, bupivacaine plus fentanyl, and bupivacaine plus tramadol after arthroscopic knee surgery. Arthroscopy. 2011 Dec;27(12):1637-43. doi: 10.1016/j.arthro.2011.08.295. Epub 2011 Nov 1.
- Li C, Qu J. Efficacy of dexmedetomidine for pain management in knee arthroscopy: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Oct;96(43):e7938. doi: 10.1097/MD.0000000000007938.
- Khanna A, Saxena R, Dutta A, Ganguly N, Sood J. Comparison of ropivacaine with and without fentanyl vs bupivacaine with fentanyl for postoperative epidural analgesia in bilateral total knee replacement surgery. J Clin Anesth. 2017 Feb;37:7-13. doi: 10.1016/j.jclinane.2016.08.020. Epub 2016 Dec 22.
- Lintner S, Shawen S, Lohnes J, Levy A, Garrett W. Local anesthesia in outpatient knee arthroscopy: a comparison of efficacy and cost. Arthroscopy. 1996 Aug;12(4):482-8. doi: 10.1016/s0749-8063(96)90044-4.
- Iwasaki K, Sudo H, Kasahara Y, Yamada K, Ohnishi T, Tsujimoto T, Iwasaki N. Effects of Multiple Intra-articular Injections of 0.5% Bupivacaine on Normal and Osteoarthritic Joints in Rats. Arthroscopy. 2016 Oct;32(10):2026-2036. doi: 10.1016/j.arthro.2016.02.011. Epub 2016 Apr 29.
- Milano G. Editorial Commentary: New Perspectives on the Intra-articular Use of Local Anesthetics: Five Weekly Injections of 0.5% Bupivacaine Does Not Alter Articular Cartilage. Arthroscopy. 2016 Oct;32(10):2037-2038. doi: 10.1016/j.arthro.2016.07.003.
- Ravnihar K, Barlic A, Drobnic M. Effect of intra-articular local anesthesia on articular cartilage in the knee. Arthroscopy. 2014 May;30(5):607-12. doi: 10.1016/j.arthro.2014.02.002.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001230620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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