Low-dose buprenorphine to prevent remifentanil-induced hyperalgesia after major lung resection: a prospective, randomised, controlled, double-blinded study

ISRCTN	ISRCTN91017061
DOI	https://doi.org/10.1186/ISRCTN91017061
Secondary identifying numbers	N/A

Submission date: 09/03/2008
Registration date: 11/12/2008
Last edited: 11/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Roberto Arcioni
Scientific

Department of Anaesthesia and Critical Care Medicine
2nd Faculty of Medicine
La Sapienza University of Rome
Sant' Andrea Hospital
Rome
00189
Italy

Email	roberto.arcioni@uniroma1.it

Study information

Study design	Single-centre, prospective, randomised, controlled, double-blinded study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Remifentanil-based general anaesthesia, oxygen, desflurane, buprenorphine, morphine
Primary outcome measure	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 study start date	01/04/2008
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/04/2008
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Italy

Study participating centre

Department of Anaesthesia and Critical Care Medicine

Rome
00189
Italy

Sponsor information

La Sapienza University of Rome (Italy)
University/education

Department of Anaesthesia and Critical Care Medicine
2nd Faculty of Medicine
Sant'Andrea Hosptial
via di Grottarossa 1035
Rome
0135
Italy

Email	roberto.arcioni@uniroma1.it
Website	http://www.uniroma1.it/
"ROR"	https://ror.org/02be6w209

Funders

Funder type

University/education

La Sapienza University of Rome (Italy) - 2nd Faculty of Medicine, Sant' Andrea Hospital, Department of Anaesthesia and Critical Care Medicine

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan