Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, single centre, randomised, parallel-group, double-blind, three doses,
      placebo-controlled, exploratory efficacy and safety study. The objective of this study is to
      investigate the efficacy and safety of a single intrathecal injection of Paracetamol 3% (30
      mg/mL) administered at 3 doses to 3 active treatment groups, as compared to placebo, for
      post-operative analgesia in knee procedures up to 40 min duration performed under spinal
      anaesthesia with Chloroprocaine HCl 1%.
    

Detailed description: 
      Eligible patients undergoing elective short-duration knee procedures up to 40 min duration
      will be randomised into 4 treatment groups (15 patients per group) to receive either one of
      the 3 single doses of Paracetamol 3% (D1: 30 mg, D2: 60 mg, D3: 90 mg) or the placebo
      solution (P: 0.9% saline solution) by intrathecal injection (IT), according to the
      randomised, parallel-group design.

      Immediately after IT paracetamol or placebo administration, all patients will receive a
      single IT dose of Chloroprocaine HCl 1% (Non-investigational medicinal product, NIMP)
      according to the Summary of Product Characteristics indications. The time interval between
      paracetamol IT and chloroprocaine IT injections should not exceed 2 min.

      The study will include a screening phase (Visit 1, Day -21/-1), a treatment phase (IMP IT
      administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase
      including an observation period (Visit 3), a final visit and two follow-ups (24 h post-dose
      and day 7±1).
    

Intervention name(s): 30 mg Paracetamol 3% (1 mL); 60 mg Paracetamol 3% (2 mL); 90 mg Paracetamol 3% (3 mL); Placebo, 0.9% saline solution; NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.; Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.; Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.; Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.; Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
Other intervention name(s): physiological solution; Ampres 1%
Intervention MeSH terms: Acetaminophen; Chloroprocaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients will be randomised into four treatment groups (15 patients/group) to receive either one of the three single doses of Paracetamol 3% (30 mg, 60 mg, 90 mg) or placebo solution (1 mL, 2 mL, 3 mL) according to the randomised, parallel-group design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care