Condition category
Skin and Connective Tissue Diseases
Date applied
09/03/2008
Date assigned
11/12/2008
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uniroma1.it/

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

Publication citations

Additional files

Editorial Notes