E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dupuytren contrature and Carpal Tunnel syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Dupuytren contracture is a hand deformity in which tissue under the skin create a thick cord Carpal tunnel syndrome is a constriction of the middle nerve at the wrist |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013873 |
E.1.2 | Term | Dupuytren's contracture operation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007697 |
E.1.2 | Term | Carpal tunnel syndrome |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to compare the onset and duration of sensory-motorblockade in subjects receiving local anesthetic injection in the distal forearm alone or separate injections in the distal and proximal forearm for hand surgery |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare postoperative pain scores, opioids intake, satisfaction with analgesia and side effects or complications. Procedural time and intraoperative discomfort caused by the tourniquet will also be compared. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- adult patients between 18 and 80 years - scheduled to undergo daycare surgery for carpal tunnel syndrome or Dupuytren's contracture release under peripheral nerve blocks - ASA I, II or III - Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick and light touch - Scheduled to undergo primary hand surgery - Able to understand the Dutch language, purpose and risks of the study - Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule and complete all study assessments
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E.4 | Principal exclusion criteria |
● Currently pregnant or, nursing patients ● History of hypersensitivity to local anesthetics ● Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine ● Medical condition that will make it difficult to assess sensory distributions of peripheral nerves or to communicate with staff ● Suspected or known recent history (< 3 months) of drug or alcohol abuse ● Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Dupuytren’s contracture and which may confound the postsurgical assessments ● Infection at the planned block site ● Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) ● Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2 ● Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments ● Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity ● Any chronic condition or disease that would compromise neurological or vascular assessments ● Presence of preexisting coagulation disorders ● Baseline neurological deficits
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is area under the curve (AUC) of the sensory-motor block scores through 7 days.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
5-minute intervals beginning at the placement of first block up to 30 minutes, then every 15 minutes until ORentrance. Sensory-motor block will be tested every 15 minutes after surgery until PACU discharge. Patients will be contacted after discharge by phone twice a day for the first 7 days after surgery and again 30 days after surgery |
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E.5.2 | Secondary end point(s) |
● Time to first pain medication use ● NRS pain intensity score through 7 days and day 30 ● Amount of opioid pain medications taken ● Subject satisfaction with overall analgesia at postoperative days 1 through 7 and day 30 ● Number of unscheduled phone calls or hospital visits related to pain after discharge
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
● NRS at baseline (prior to the nerve block): 1 and 2 hours, at hospital discharge, and twice a day in the first 7 days after surgery ● Date, time and amount of all pain medication taken in the first 7 days after surgery ● Subject satisfaction with overall analgesia twice a day in the first 7 days after surgery
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patients can be included within 1 year. Evaluation will take longer until 1 month after the last patient is included. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |