Pain, PostoperativePhase 2NCT03428230
Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures
A Phase 2 study testing 30 mg Paracetamol 3% (1 mL), 60 mg Paracetamol 3% (2 mL) and 90 mg Paracetamol 3% (3 mL) in people with Pain, Postoperative, run by Sintetica SA at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 30 mg Paracetamol 3% (1 mL), 60 mg Paracetamol 3% (2 mL) and 90 mg Paracetamol 3% (3 mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Aug 2018to 22 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study
- Sex, age and surgery: male/female patients, 18-80 years old (inclusive), scheduled for short duration (up to 40 min) knee procedures
- Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- ASA physical status: I-III
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
Who cannot join
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- ASA physical status: IV-V
- Further anaesthesia: patients expected to require further anaesthesia
- Allergy: ascertained or presumptive hypersensitivity to the active principles (paracetamol and/or ester type anaesthetics) and/or formulations' ingredients or related drugs, non-steroidal anti-inflammatory drugs and/or opioid derivatives; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study
- Chronic pain syndromes: patients with chronic pain syndromes taking opioids, anticonvulsant agents or chronic analgesic therapy
- Pain assessment: patients anticipated to be unable to make a reliable self-report of pain intensity
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- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes, other neuropathies, history or evidence of heart failure. History of severe head trauma that required hospitalisation, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion
- Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Paracetamol formulations, other than the investigational product, for 2 weeks before the start of the study and during the study. Hormonal contraceptives for females are allowed. Anti-hypotensive, anti-bradycardia (e.g. ephedrine, atropine, Ringer's solution), anti-haemetic and anti-nausea medications will be allowed
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- Drug, alcohol: history of drug or alcohol abuse according to the Investigator's opinion
- Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating women [The pregnancy test will be performed to all fertile women and to all women up to 55 years old, if not in proven menopause (available laboratory test confirming menopause or surgically sterilised)]
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology, Clinica Ars Medica
Gravesano, 6929
About this study
Official title: Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Knee Procedures of Short Duration
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%.
Read the 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).
- Conditions
- Pain, Postoperative
- Being tested
- 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
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 mg Paracetamol 3% (1 mL)Drug
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.
60 mg Paracetamol 3% (2 mL)Drug
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.
90 mg Paracetamol 3% (3 mL)Drug
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.
Placebo, 0.9% saline solutionDrug
Also called physiological solution
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.
NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injectionDrug
Also called Ampres 1%
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.
| Study group | Role | What they receive |
|---|---|---|
| 30 mg Paracetamol 3% (1 mL) | Experimental | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) Receives: Drug: 30 mg Paracetamol 3% (1 mL); Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection |
| 60 mg Paracetamol 3% (2 mL) | Experimental | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) Receives: Drug: 60 mg Paracetamol 3% (2 mL); Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection |
| 90 mg Paracetamol 3% (3 mL) | Experimental | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) Receives: Drug: 90 mg Paracetamol 3% (3 mL); Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection |
| Placebo, 0.9% saline solution | Placebo comparator | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Receives: Drug: Placebo, 0.9% saline solution; Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at Rest Evaluated Using a 0-100 mm VAS
The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain)
Measured: Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.
Secondary outcomes (21)
Pain at Rest AUCt1-t2
AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals
Measured: Up to 4 hours after injection
Pain at Rest AUClast
AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time
Measured: Up to 24 hours after injection
Time to First Postoperative Analgesia (Level 1 or 2)
Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia).
The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity.
Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia).
Measured: Up to 24 hours after surgery
Partecipants to Received Level 1 Analgesia
Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia)
Measured: from surgery day to 24 hours after surgery
Partecipants Received Level 2 Analgesia
Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia)
Measured: from surgery day to 24 hours after surgery
Total Number of Partecipants Receiving Analgesic 1
Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg
Measured: From surgery day to 24 hours after surgery
Total Number of Partecipants Receiving Analgesic 2
Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg
Measured: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End
Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end
Measured: Form surgery day to 2 hours after surgery end
Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End
Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end
Measured: from surgery day to 4 hours after surgery end
Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge
Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge
Measured: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge
Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge
Measured: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge
Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge
Measured: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia
Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia
Measured: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Rescue Anaesthesia
Percentage of patients requiring rescue anaesthesia
Measured: from surgery day to 1 hour after injection
Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)
Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery.
Measured: Up to 20 minutes after injection
Maximum Sensory Block
Maximum level of sensory block
Measured: Intraoperative
Time to Sensory Block
Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle)
Measured: Intraoperative
Time to Regression of Spinal Block
Time period from spinal injection to the complete regression of sensory block to S1.
Measured: Up to 4 hours after injection
Time to Ambulation
Time to unassisted ambulation
Measured: Up to 24 hours after injection
Time to First Urine
Time to first spontaneous urine voiding
Measured: Up to 24 hours after injection
Time to Eligibility for Discharge
Time to eligibility for home discharge
Measured: Up to 24 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start6 Aug 2018
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Claudio Camponovo, MD, Principal investigator, Department of Anaesthesiology, Clinica Ars Medica, Via Cantonale, CH-6929 Gravesano, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428230
- Sponsor's protocol ID
- PAR.3-01-2017
- Other IDs
- CRO-17-133
- Status last verified
- Jun 2021
- First submitted
- 23 Jan 2018
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Knee Procedures of Short Duration
- ClinicalTrials.gov ID
- NCT03428230
- Acronym / sponsor ID
- PAR.3-01-2017
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 30 mg Paracetamol 3% (1 mL) | Experimental | Drug: 30 mg Paracetamol 3% (1 mL), Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) |
| 60 mg Paracetamol 3% (2 mL) | Experimental | Drug: 60 mg Paracetamol 3% (2 mL), Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) |
| 90 mg Paracetamol 3% (3 mL) | Experimental | Drug: 90 mg Paracetamol 3% (3 mL), Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) |
| Placebo, 0.9% saline solution | Placebo comparator | Drug: Placebo, 0.9% saline solution, Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injectionPlacebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent: signed written informed consent before inclusion in the study
- Sex, age and surgery: male/female patients, 18-80 years old (inclusive), scheduled for short duration (up to 40 min) knee procedures
- Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- ASA physical status: I-III
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
Key exclusion criteria (11 listed)
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- ASA physical status: IV-V
- Further anaesthesia: patients expected to require further anaesthesia
- Allergy: ascertained or presumptive hypersensitivity to the active principles (paracetamol and/or ester type anaesthetics) and/or formulations' ingredients or related drugs, non-steroidal anti-inflammatory drugs and/or opioid derivatives; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study
- Chronic pain syndromes: patients with chronic pain syndromes taking opioids, anticonvulsant agents or chronic analgesic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 mg Paracetamol 3% (1 mL)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. | Drug | 30 mg Paracetamol 3% (1 mL) |
| 60 mg Paracetamol 3% (2 mL)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. | Drug | 60 mg Paracetamol 3% (2 mL) |
| 90 mg Paracetamol 3% (3 mL)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. | Drug | 90 mg Paracetamol 3% (3 mL) |
| Placebo, 0.9% saline solutionAlso: physiological solutionSingle 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. | Drug | Placebo, 0.9% saline solution |
| NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injectionAlso: Ampres 1%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. | Drug | 30 mg Paracetamol 3% (1 mL), 60 mg Paracetamol 3% (2 mL), 90 mg Paracetamol 3% (3 mL), Placebo, 0.9% saline solution |
Primary outcome
Pain Intensity at Rest Evaluated Using a 0-100 mm VAS
Time frame: Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.
The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain)
21 secondary outcomes
Pain at Rest AUCt1-t2
Time frame: Up to 4 hours after injection
Pain at Rest AUClast
Time frame: Up to 24 hours after injection
Time to First Postoperative Analgesia (Level 1 or 2)
Time frame: Up to 24 hours after surgery
Partecipants to Received Level 1 Analgesia
Time frame: from surgery day to 24 hours after surgery
Partecipants Received Level 2 Analgesia
Time frame: from surgery day to 24 hours after surgery
Total Number of Partecipants Receiving Analgesic 1
Time frame: From surgery day to 24 hours after surgery
Total Number of Partecipants Receiving Analgesic 2
Time frame: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End
Time frame: Form surgery day to 2 hours after surgery end
Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End
Time frame: from surgery day to 4 hours after surgery end
Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge
Time frame: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge
Time frame: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge
Time frame: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia
Time frame: from surgery day to 24 hours after surgery
Percentage of Patients Requiring Rescue Anaesthesia
Time frame: from surgery day to 1 hour after injection
Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)
Time frame: Up to 20 minutes after injection
Maximum Sensory Block
Time frame: Intraoperative
Time to Sensory Block
Time frame: Intraoperative
Time to Regression of Spinal Block
Time frame: Up to 4 hours after injection
Time to Ambulation
Time frame: Up to 24 hours after injection
Time to First Urine
Time frame: Up to 24 hours after injection
Time to Eligibility for Discharge
Time frame: Up to 24 hours after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Camponovo, MD principal investigator
Department of Anaesthesiology, Clinica Ars Medica, Via Cantonale, CH-6929 Gravesano, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 30 mg Paracetamol 3% (1 mL), 60 mg Paracetamol 3% (2 mL) and 90 mg Paracetamol 3% (3 mL) in people with Pain, Postoperative, run by Sintetica SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity at Rest Evaluated Using a 0-100 mm VAS (time frame: Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.