PRA-167501 Anesthesia € 2.092,-

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Description

Study of a new compound that is being developed for regional anesthesia and postoperative analgesia

Requested participants

  • Male, healthy, 18 - 55 years old

Duration and visits

  • 9 days stay
  • 1 day Follow-up

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Research details

Particulars

  • Your body weight must be at least 60 kg and your Body Mass Index (BMI) is between 20 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
  • Both non-smokers and light smokers can participate in this study, however, smoking is not allowed during your stay in the research facility.
  • During this study the study drug will be given by an anesthesiologist from the University Medical Center Groningen (UMCG) as a perineural injection (an injection in the neck region in the tissue surrounding the nerves that run from the cervical spinal cord to the arm, called interscalene brachial plexus blockade).
  • Through this injection, the arm will become temporarily numb and it can temporarily no longer be moved. 
  • To determine if you are suitable to participate in this study, you will undergo a medical screening that will take place within 30 days prior to the start of the study period.
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Compensation

You will receive a gross compensation of € 2.092,- for participation in one of the groups of this study.

Travelling expenses will be reimbursed based on the distance traveled (€ 0,19 net per kilometer) with a minimum of € 12,- and a maximum of € 160,- (840 kilometers) per return, regardless of the mode of transportation.

Period of stay and research

For all parts (Part A, B and C) the study will consist of 1 period during which you will stay in our research facility in Groningen (Martini site) for a minimum of 5 days (4 nights) and a maximum of 9 days (8 nights), followed by a follow-up visit. The day of departure from the research facility depends on the extent to which the feeling in the arm and the ability to move the arm have returned again.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Information sheet PRA-167501

Type of study

The purpose of the study is to investigate how safe the new compound is when it is administered to healthy male volunteers alone and in combination with bupivacaine (with and without epinephrine). It will also be investigated how quickly and to what extent the new compound is absorbed and eliminated from the body. In addition, the effect of the new compound on the body will be investigated.

The new compound is not registered as a drug but has been given to humans before. The other compounds that will be given in this study (bupivacaine and epinephrine) are approved drugs and already available in the market under several dosages and formulations. Bupivacaine is used as a local anesthetic for surgical anesthesia and treatment of acute pain. Epinephrine is used as a substance that can enhance the effects of another substance for peripheral nerve blocks, which leads to narrowing of blood vessels, so the duration of the block is prolonged. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

The study will be performed in 3 parts: Part A, Part B and Part C.

For all parts (Part A, B and C) the study will consist of 1 period during which you will stay in our research facility in Groningen (Martini site) for a minimum of 5 days (4 nights) and a maximum of 9 days (8 nights). In this study the new compound alone or in combination with bupivacaine and/or epinephrine will be given as a perineural injection by a certified anesthesiologist from the University Medical Center Groningen (UMCG) with extensive experience in this technique. A perineural injection is an injection around the nerves. This takes place at the lateral side of the neck to locally anesthetize the network of nerves (the so-called plexus) that run from the cervical spinal cord to the arm (the so-called plexus brachialis). The study compound(s) will give local anesthesia of the arm by induction of a brachial plexus blockade which means that temporarily the sensation of your arm and ability to move your arm is blocked. The day of departure depends on the extent to which the feeling in the arm and the ability to move the arm have returned again. If deemed necessary, a short acting subcutaneous local anesthesia (lidocaine) will be used at the injection site, prior the brachial plexus blockade.

Each group will consist of 5 volunteers. The following treatments will be administered to each group of volunteers in each part (which treatment you will receive within each group and/or part, will be determined by chance):

In each group of Part A, one of the following single dose administrations will be given: the new compound combined with 40mg bupivacaine and epinephrine (3 volunteers), 40mg bupivacaine and epinephrine (1 volunteer) or 100mg bupivacaine and epinephrine (1 volunteer).

In each group of Part B one of the following single dose administrations will be given: the new compound combined with 10-80mg bupivacaine (3 volunteers), 10-80mg bupivacaine (1 volunteer) or 100mg bupivacaine (1 volunteer).

In Part C, one of the following single dose administrations will be given: the new compound combined with bupivacaine and epinephrine (up to 6 volunteers), the new compound combined with bupivacaine (up to 3 volunteers), the new compound (6 volunteers) or the new compound combined with epinephrine (6 volunteers). The dose level of bupivacaine and the new compound will be the same for the applicable administrations and will be determined based on the results of Part B of the study.

Blood samples will be taken regularly during the study. In addition, we will measure your lung function and the oxygen level in your blood, make an ultrasound of your diaphragm and perform some muscle strength and function tests and sensory tests at your arm at several time points during the study. Also your hearth rhythm will be monitored continuously from just before administration of the study compound until 24 hours thereafter by Telemetry.

Risks and medical supervision

The new compound may eventually be used for surgical anesthesia and postoperative analgesia. Such anesthesia is often performed in hospitals when people are being operated on. At that time the anesthesia can be done in addition to narcosis. These anesthetics are also called ‘regional anesthesia’, ‘nerve block’ or simply ‘blockade’. The nerves that run to the area that is being operated on are then numbed. This is done by an injection with a local anesthetic in the area of those nerves (perineural injection).

The new compound is a member of a group of molecules known as sodium channel blockers. Sodium channels are membrane proteins that form ion channels, conducting sodium ions through a cell’s plasma membrane. The new compound produces reversible conduction blockade of the sodium channels and in this way stops the distribution of the nerve impulse. As a result, no initiation or conduction of a pain signal can occur. This effect of blockade is similar to what local anesthetics are doing, e.g., at the dentist. Bupivacaine is used as a local anesthetic for surgical anesthesia and treatment of acute pain. Epinephrine is used as an adjuvant (a substance that can enhance the effects of another substance) for peripheral nerve blocks leading to narrowing of the blood vessels, prolonging exposure of the nerve to the local anesthetic, thus leading to prolongation of the block duration. Bupivacaine will be given with or without epinephrine during this study.

All potential drugs can cause adverse effects; the extent to which this occurs differs. In 4 other clinical studies 286 healthy volunteers have been exposed to the new compound alone, or in combination with bupivacaine and/or epinephrine. The most common reported adverse effects were oral paresthesia (an abnormal sensation, typically tingling or pricking of the mouth) and oral hypoesthesia (reduced sense of touch or sensation of the mouth; numbness).

In this study epinephrine is used in a low dose (usual as adjunct to local anesthesia) in combination with the new compound. When it is used as recommended, no adverse effects are expected from the use of epinephrine in addition to those of the new compound.

The most frequently observed side effects of bupivacaine (with or without epinephrine) were nausea, low blood pressure, paresthesia (an abnormal sensation, typically tingling or pricking), dizziness, slow heart rate, vomiting and high blood pressure.

You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.

Conditions for participation

You are a healthy male between 18 and 55 years of age. Your body weight is at least 60 kg and your Body Mass Index (BMI) is between 20 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and body height in meters. You can only take part in the study if you do not smoke or if you do not smoke more than 10 cigarettes, 2 cigars of 2 pipes per day within 6 months prior the medical screening and if you are able to abstain from smoking during your stay in the research center.

The study will be executed under standardized conditions. Use of your own medication, alcohol, drugs of abuse, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate) and grapefruit (juice) during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within 30 days before the start of the study.

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Group B1a

€ 2.092,-

9 days stay

  • 1 Jul 2018 up to and including 9 Jul 2018

short stay

Inapplicable

Follow-up

  • 13 Jul 2018

Group B1b

€ 2.092,-

9 days stay

  • 2 Jul 2018 up to and including 10 Jul 2018

short stay

Inapplicable

Follow-up

  • 13 Jul 2018

Group B1c

€ 2.092,-

9 days stay

  • 3 Jul 2018 up to and including 11 Jul 2018

short stay

Inapplicable

Follow-up

  • 13 Jul 2018

Group A6a

€ 2.092,-

9 days stay

  • 15 Jul 2018 up to and including 23 Jul 2018

short stay

Inapplicable

Follow-up

  • 27 Jul 2018

Group A6b

€ 2.092,-

9 days stay

  • 16 Jul 2018 up to and including 24 Jul 2018

short stay

Inapplicable

Follow-up

  • 27 Jul 2018

Group A6c

€ 2.092,-

9 days stay

  • 17 Jul 2018 up to and including 25 Jul 2018

short stay

Inapplicable

Follow-up

  • 27 Jul 2018

Group A5a

€ 2.092,-

9 days stay

  • 17 Jun 2018 up to and including 25 Jun 2018

short stay

Inapplicable

Follow-up

  • 29 Jun 2018
Group full

Group A5b

€ 2.092,-

9 days stay

  • 18 Jun 2018 up to and including 26 Jun 2018

short stay

Inapplicable

Follow-up

  • 29 Jun 2018
Group full

Group A5c

€ 2.092,-

9 days stay

  • 19 Jun 2018 up to and including 27 Jun 2018

short stay

Inapplicable

Follow-up

  • 29 Jun 2018
Group full

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