Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery
Condition: Pain, Postoperative; Analgesic Adverse Reaction; Cruciate Ligament Rupture
MeSH terms: Pain, Postoperative; Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      The clinical study is planned as a double-blind, randomised, placebo-controlled,
      parallel-group, single-centre exploratory clinical study with the aim to investigate the
      analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac
      only infusion. Included will be Patients receiving elective cruciate ligament surgery. The
      effectiveness will be measured by the use of additional analgesic medication via PCA during
      the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS).
      Furthermore the local and systemic tolerability and safety of the clinical study medications
      (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.
    

Detailed description: 
      The clinical study is planned as a double-blind, randomised, treatment-controlled,
      parallel-group, single-centre exploratory clinical study with the aim to investigate the
      analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac
      only infusion.

      Patients who meet the inclusion and exclusion criteria will be enrolled to the clinical study
      and receive an enrolment number. The enrolment number will be a 4-digit number where the
      leftmost position will be zero ("0"). Enrolled patients will receive enrolment numbers
      starting at 0001, 0002, and so forth.

      Only patients who were successfully randomized after surgery will continue the study
      protocol. All other patients will be regarded as screening failures. Successfully randomized
      patients will receive two infusions over 60 - 90 minutes with a time interval of 8 hours each
      during the first 24 hours postoperatively. All patients will be provided with a PCA device
      and will be allowed on demand analgetics as postoperative rescue medication. Consequently the
      possibility of an inadequate postoperative pain treatment in the study patients is very low.

      Anaesthesia will be induced with propofol (1.0-2.5 mg/kg), remifentanil (1 mcg/kg over
      minimum of 30s) and rocuronium (0.6mg/kg) and subsequently maintained with remifentail (0.25
      - 1 mcg/kg/min), and sevoflurane. During skin suture, 7.5 mg piritramid will be administered.
      No nitrous oxide will be administered.

      No other narcotics, analgesics, or sedatives than those described herein will be allowed. In
      case the surgical procedure mandates the use of additional and/or other narcotics,
      analgesics, or sedatives it shall be up to the investigator to decide on further treatment.
      However, in such case the patient will not be randomized and will be regarded as screening
      failure.

      Randomization of the study patient takes place post-surgery as soon as the patient is able to
      cooperate adequatey. Ability to cooperate is defined as successful VAS assessment. At this
      time point the patient will be randomized and assigned her/his final randomisation number.
      The final randomisation number will be a 4-digit number where the leftmost position
      indicating the type of knee surgery performed. Patient undergoing surgery for cruciate
      ligament repair will receive randomisation numbers starting at 1001, 1002, and so forth.
      Patients undergoing knee replacement surgery will receive randomisation numbers starting at
      2001, 2002, and so forth.

      The first infusion of the investigational medicinal product will be started immediately after
      randomization. PCA will be established as soon as possible after the start of the first
      infusion of the investigational medicinal product but not later than 30 min after the start
      of the first infusion of the investigational medicinal product. A one-way PCA device (Vygon
      PCA-System) will be used. The PCA system is independent from any power supply and therefore
      both safe and reliable. The PCA system contains 20 mg Hydal® (hydromorphone) in 50 mL
      solvent. The PCA system parameters are fixed to a single bolus volume of 0.5 mL thus
      delivering 0.2 mg hydromorphone per bolus which equates to 2.0 mg piritramide or 1.5 mg
      morphine. Lock-out period of the PCA system used is fixed to 5 min.

      All bolus injections will be recorded and added to the cumulative analgesic doses delivered
      by PCA.
    

Intervention name(s): Neodolpasse; Diclofenac; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.; Patients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.; Patients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization of the study patient takes place pre-surgery. Successfully randomized patients will receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low, also in the placebo group.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Double-Blind Method; placebo-controlled; parallel-group; single-centre; exploratory clinical study