Hyperalgesia and Pain

Hyperalgesia Clinical Trial

Official title:

Evaluation of Antihyperalgesic and Analgesic Effects of 35% Nitrous Oxide in a Human Model of Electrically Evoked Hyperalgesia and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581450
• Other study ID #: 2011-000966-37
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2011
• Last updated: April 19, 2012
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in 20 healthy volunteers.

The duration of participation for each volunteer is expected to be around 9 weeks with the performance of 4 experimental session 2 weeks apart.

The selection visit will last half a day; each experimental session will last half a day; the study end will last 2 hours maximum.

Description:

Single site, exploratory, comparative, double-blind, randomised, cross-over study. Three physicians will be involved in the conduct of this study:

• Physician 1 will include and randomise the subjects, prepare and administer the study products (namely Investigational Medicinal Products (IMPs)) in an open manner and will assess subject safety.

• Physician 2, kept IMP blinded, will perform all evaluation measurements and sedation assessments during all experimental sessions. Physician 2 will always be the same person throughout the whole study period.

• Physician 3 will be available if needed to reinforce subject safety

Design: A group of 20 assessable subjects who will undergo 4 randomised experimental sessions of CCES on 4 separate study days, 2 weeks apart preceded by a 2 week period between selection and first experimental session and followed by a 1 week period between last experimental session and study end.

After the selection visit, each visit corresponds to one of the 4 experimental sessions named A, B, C, D differing by the gas mixture inhaled and the intravenous medicine administered.

The order of these experimental sessions A, B, C, D, will be assigned according to a pre-established list that the investigator will not know.

Each experimental session includes a set-up-phase followed by an evaluation phase.

The set up phase will last 20 mn during each an electrical stimulation will generate a spontaneous pain: every 2 minutes the electrical stimulation will increase and the subject will be asked to rate the pain on a visual scale from 0 to 100. When a stable levels of pain intensity will be reached, the regimen of the electrical stimulation will be kept constant up to the end of the experimental session.

The Evaluation phase will last 160 mn : the electrical stimulation will be constant during 160 mn as detailed above. During this phase the subject will inhale a gas mixture with a face mask during 60 minutes combined with an intravenous administration of medicine during 30 mn starting at the same time.

Every 5 minutes the subject will be asked to rate the pain and at predefined times the spontaneous pain and the area of allodynia and hyperalgesia will be measured and recorded as well as safety parameters (transcutaneous oxygen saturation, respiratory parameters, sedation score, blood pressure and heart rate).

The 4 experimental sessions named A, B, C, D differ by the gas mixture inhaled and the intravenous medicine administered.

For the placebo session, inhaled gas mixture will be 50%/50% N2/O2 and intravenous administration will be an isotonic saline solution.

For the three other sessions, inhaled gas mixture will differ from a session to the other one (35%/15%/50% N2O/N2/O2 or 50%/50% N2/O2 or 50%/50% N2O/O2), and remifentanil will be administered intravenously at each of these sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Caucasian healthy male

• Able to feel a distinct pin-pick sensation on normal skin

• Subject willing and able to complete the requirements of this study

• Written informed consent signed prior to any study related procedures

Exclusion Criteria:

• History of any past or current renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine haematological, neurological, psychiatric disease or other disorders

• Any significant history of allergic disease

• Acute skin disease, lesions, acute sunburn, extensive tattoos or scars

• Donation of blood within the previous 3 months

• participation in any other clinical study within the previous 4 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

Drug:
• Nitrous Oxide
35%
• Nitrous Oxide
50%

Locations

Country	Name	City	State
Germany	University of Erlangen - Nürnberg	Erlangen
Germany	University of Erlangen - Nürnberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	ORION Clinical Services

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperalgesia	- Hyperalgesia will be assessed by using a metal rod,(in unit cm).	at T0, T10, T25, T40, T55, T70, T95, T110, T125, T140 and T155 minutes at each experimental session which will last half day	No
Secondary	transcutaneous oxygen saturation	By monitoring pulse oximetry device	From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day	Yes
Secondary	respiration rate	Respiration rate	From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day	Yes
Secondary	systolic and diastolic blood pressures	systolic and diastolic blood pressures	From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day	Yes
Secondary	Heart rate	Measured by cardioscope	From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day	Yes
Secondary	sedation score	sedation score	From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day	Yes