Ropivacaine and Midazolam by Intraarticular vs Epidural Administration in Arthroscopic ACL

NCT05078372 | Completed Phase 2 DMC

• 1 other identifier: AN19-00003
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Compare of the effectiveness of the use of ropivacaine and midazolam by intraarticular vs epidural administration on post-operative analgesia after isolated arthroscopic anterior cruciate ligament (ACL) reconstruction with hamstring autograft.

Conditions

Anterior Cruciate Ligament Injuries; Anesthesia Injection Site; Knee Injuries

Keywords

Knee infiltration; Anterior Cruciate Ligament; Hamstring; Ropivacaine; Midazolam

Outcome Measures

Primary Outcomes (1)

• Post-operative analgesic request

  All the medication utilized posterior to the surgery was recorded and administered in case of pain with a VAS greater than 4, the administration of 1g of acetaminophen, 30 mg IV of ketorolac and 50 mg IV of Tramadol was indicated, in any of the 2 groups, which could be repeated every 8 hours if required.

  will be measured at 24 hours after surgery

Secondary Outcomes (4)

• Therapeutic effect on visual analog scale

  Pain will be measured at 2, 6, 12 , 24 and 48 hours after surgery.

• Side effects of analgesic drugs

  Hemoglobin levels will be measured at 2, 6, 12 , 24 and 48 hours after surgery.]

• Postoperative range of motion

  at 24 and 48 hours after surgery.]

• Post-operative analgesic request

  will be measured at 2, 6, 12 , 24 and 48 hours after surgery.

Study Arms (2)

Ropivacaine and midazolam epidural administration

ACTIVE COMPARATOR

An elastomeric pump was prepared for epidural infusion. This was prepared with 150 mg (20 ml) of 0.75% ropivacaine plus midazolam at 50 mcg / kg / 12 hrs. The solution was made up to 125 ml with physiological solution. And 20 ml of physiological solution, was intraarticular administered as placebo.

Drug: ropivacaine and midazolam epidural administration

Ropivacaine and midazolam intraarticular administration

ACTIVE COMPARATOR

Ropivacaine 0.75% at 1.5 mg / kg was used with midazolam at 50 mcg / kg, to complete 20 ml of solution and was administrated on the knee articulation after tourniquet release. And an elastomeric pump was prepared for epidural infusion, with 150 ml of physiological solution as placebo.

Drug: ropivacaine and midazolam intraarticular administration

Interventions

ropivacaine and midazolam intraarticular administration DRUG

Patients undergoing ACL reconstruction with hamstring autograft who will receive ropivacaine and midazolam epidural administration for anesthesic technique for the procedure, and intraarticular administration of those drugs.

Also known as: Ropiconest®, Ralecum®

Ropivacaine and midazolam intraarticular administration

ropivacaine and midazolam epidural administration DRUG

Patients undergoing ACL reconstruction with hamstring autograft who will receive ropivacaine and midazolam epidural administration for anesthesic technique for the procedure

Also known as: Ropiconest®, Ralecum®

Ropivacaine and midazolam epidural administration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age over 18 years and younger than 50 years
• Arthroscopic single bundle anterior cruciate ligament anatomic reconstruction with hamstring tendon autograft
• Unilateral procedure
• With or without meniscal tear
• Desire to participate voluntarily in the study and signature of informed consent
• Pre-operative assessment with result between (American Society of Anesthesiologist) ASA I or ASA II performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology.

You may not qualify if:

• Another ligament surgery (posterior cruciate ligament, medial collateral ligament, posterolateral corner reconstruction)
• ACL reconstruction with allograft
• Bone to bone or quadriceps autograft
• ACL reconstruction with double bundle technique
• Patients with previous knee surgeries
• Open ACL reconstruction
• Corrective knee osteotomy or articular cartilage repair surgery, meniscal transplant, lateral extraarticular tenodesis
• Pregnant or lactating patients
• Patients under 18 years old
• Patients consuming oral contraceptives
• Patients who present any contraindication for neuraxial blockade (e.g., coagulation defects, infection at the puncture site, pre-existing neurological deficits in the lower extremities, Anticoagulant or antiplatelet therapy that has not been suspended 48 hours before the surgery, systemic infection, fever above 38.5º)
• Preoperative assessment with ASA III-IV
• Hypersensitivity to the drugs used in the study
• Patients with intellectual impairments or psychiatric conditions that limited adequate communication
• Patients with a diagnosis of fibromyalgia, polymyalgia rheumatica, complex painful syndromes or sciatic neuropathy

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (12)

• Baldawi M, McKelvey G, Saasouh W, Perov S, Mostafa G, Saleh K. A Comparison of Neuraxial and General Anesthesia for Thirty-Day Postoperative Outcomes in United States Veterans Undergoing Total Knee Arthroplasty. J Arthroplasty. 2020 Nov;35(11):3138-3144. doi: 10.1016/j.arth.2020.06.030. Epub 2020 Jun 17.

  PMID: 32641270 RESULT

• Baverel L, Cucurulo T, Lutz C, Colombet, Cournapeau J, Dalmay F, Lefevre N, Letartre R, Potel JF, Roussignol X, Surdeau L, Servien E; French Arthroscopic Society. Anesthesia and analgesia methods for outpatient anterior cruciate ligament reconstruction. Orthop Traumatol Surg Res. 2016 Dec;102(8S):S251-S255. doi: 10.1016/j.otsr.2016.08.007. Epub 2016 Sep 26.

  PMID: 27687059 RESULT

• Dauri M, Polzoni M, Fabbi E, Sidiropoulou T, Servetti S, Coniglione F, Mariani P, Sabato AF. Comparison of epidural, continuous femoral block and intraarticular analgesia after anterior cruciate ligament reconstruction. Acta Anaesthesiol Scand. 2003 Jan;47(1):20-5. doi: 10.1034/j.1399-6576.2003.470104.x.

  PMID: 12492792 RESULT

• Hong AJ, Agarwalla A, Liu JN, Gowd AK, McMillan S, Sethi PM, Amin NH. Neurological structures and mediators of pain sensation in anterior cruciate ligament reconstruction. Ann Anat. 2019 Sep;225:28-32. doi: 10.1016/j.aanat.2019.05.010. Epub 2019 Jun 11.

  PMID: 31195095 RESULT

• Johnson RL, Kopp SL, Burkle CM, Duncan CM, Jacob AK, Erwin PJ, Murad MH, Mantilla CB. Neuraxial vs general anaesthesia for total hip and total knee arthroplasty: a systematic review of comparative-effectiveness research. Br J Anaesth. 2016 Feb;116(2):163-76. doi: 10.1093/bja/aev455.

  PMID: 26787787 RESULT

• Lauretti GR, de Oliveira R, Perez MV, Paccola CA. Postoperative analgesia by intraarticular and epidural neostigmine following knee surgery. J Clin Anesth. 2000 Sep;12(6):444-8. doi: 10.1016/s0952-8180(00)00189-6.

  PMID: 11090729 RESULT

• Nahravani M, Tekye SM, Alipour M, Makhmalbaf H, Aghaee MA. Analgesia Following Arthroscopy - a Comparison of Intra-articular Bupivacaine and/or Midazolam and or Fentanyl. Arch Bone Jt Surg. 2017 Jan;5(1):28-31.

  PMID: 28271084 RESULT

• Padwal JA, Burton BN, Fiallo AA, Swisher MW, Gabriel RA. The association of neuraxial versus general anesthesia with inpatient admission following arthroscopic knee surgery. J Clin Anesth. 2019 Sep;56:145-150. doi: 10.1016/j.jclinane.2019.01.045. Epub 2019 Feb 23.

  PMID: 30807886 RESULT

• Parker RD, Streem K, Schmitz L, Martineau PA; Marguerite Group. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: a double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007 Apr;35(4):531-6. doi: 10.1177/0363546506296313. Epub 2007 Jan 23.

  PMID: 17244900 RESULT

• Peng K, Chen WR, Meng XW, Zhang J, Ji FH. Intra-articular dexmedetomidine in knee arthroscopy: A systematic review and meta-analysis. Sci Rep. 2018 Mar 6;8(1):4089. doi: 10.1038/s41598-018-22482-8.

  PMID: 29511256 RESULT

• 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.

  PMID: 26049805 RESULT

• 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.

  PMID: 27140500 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rodolfo Morales-Avalos, MSc, MD

  University Hospital "Dr. José Eleuterio González", Universidad Autonoma de Nuevo León (U.A.N.L.)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Prior to being included in the study, the patient will be mentioned the times when he will receive the medication as well as the dosage of administration. The patient will not know what medication is being administered to him / her. The drug will be given to the anesthesist in unlabeled syringes without access to any information legend. In the same way, the study group only will be know by a doctor outside the research protocol and will not participate in any other phase of the study so that no member of the research team will know what medication was administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: Two study groups will be generated, each consisting of 54 research subjects, randomly each recipient will receive epidural anesthesia with or without intraarticular ropivacaine. The group to which the patient belongs will be assigned through a computer program, the patient will not know to which group he belongs or what medication he will receive. The patients will be extracted from the external traumatology clinic

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 14, 2021
• Study Start: January 31, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 5, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-09

Locations

ME (1)