Contact information
Type
Scientific
Primary contact
Prof Roberto Arcioni
ORCID ID
Contact details
Department of Anaesthesia and Critical Care Medicine
2nd Faculty of Medicine
La Sapienza University of Rome
Sant' Andrea Hospital
Rome
00189
Italy
roberto.arcioni@uniroma1.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Remifentanil is now considered one of the favourite agents for fast-track surgery. Despite its advantages, a remifentanil-based general anaesthesia seems to increase post-operative hyperalgesia, mainly during long or painful surgical procedures.
Treating acute post-operative remifentanil-induced hyperalgesia could have several benefits:
1. It could decrease post-operative stress reducing morbidity after surgery, improving patients outcomes and clinical expense
2. It could decrease analgesic related side effects and improve post-operative pulmonary function
3. It could reduce chronic pain outcomes after surgery
Recent evidences, both experimental and clinical, showed the role of N-methyl D-aspartate (NMDA)-receptor antagonists to prevent remifentanil-induced hyperalgesia. Among all the NMDA-antagonists commercially available, buprenorphine has unique and attractive features.
Hypothesis:
Does a low-dose continuous intra- and post-operative infusion of buprenorphine prevent remifentanil-induced hyperalgesia after open thoracic surgery, reducing post-operative morphine consumption and the extension of the primary hyperalgesic area around the incision site?
Ethics approval
Not provided at time of registration
Study design
Single-centre, prospective, randomised, controlled, double-blinded study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Post-operative remifentanil-induced hyperalgesia
Intervention
All patients will receive remifentanil based general anaesthesia (target-controlled infusion [TCI] system), supplemented with oxygen and desflurane. Patients will then be randomised to:
1. Buprenorphine group: intra- and post-operative infusion of 25 µg/h of buprenorphine for 24 hours
2. Morphine group: intra- and post-operative infusion of 834 µg/h of morphine for 24 hours
Follow-up will occur until 30 days after hospital discharge.
Intervention type
Drug
Phase
Not Specified
Drug names
Remifentanil-based general anaesthesia, oxygen, desflurane, buprenorphine, morphine
Primary outcome measures
Post-operative morphine consumption (PCA).
Secondary outcome measures
1. Morphine titration at the end of the surgery
2. Visual Analogue Scale (VAS) at rest and during coughing at 24 and 48 hours
3. Hyperalgesic area at 24 and 48 hours (Quantitative Sensory Testing)
4. Length of post-operative hospitalisation
5. Incidence of post-thoracotomy pain after one month from surgery
Overall trial start date
01/04/2008
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients (American Society of Anaesthesiologists [ASA] grade I - III) undergoing major lung resections
2. Aged greater than 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Extremely high or low weight (less than 40 kg and greater than 100 kg)
2. Known abuse of opioid drugs
3. Patients unable to manage a patient-controlled analgesia (PCA) device
Recruitment start date
01/04/2008
Recruitment end date
01/10/2008
Locations
Countries of recruitment
Italy
Trial participating centre
Department of Anaesthesia and Critical Care Medicine
Rome
00189
Italy
Sponsor information
Organisation
La Sapienza University of Rome (Italy)
Sponsor details
Department of Anaesthesia and Critical Care Medicine
2nd Faculty of Medicine
Sant'Andrea Hosptial
via di Grottarossa 1035
Rome
0135
Italy
roberto.arcioni@uniroma1.it
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
La Sapienza University of Rome (Italy) - 2nd Faculty of Medicine, Sant' Andrea Hospital, Department of Anaesthesia and Critical Care Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary