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 |
| Protocol serial number | N/A |
| Sponsor | La Sapienza University of Rome (Italy) |
| Funder | La Sapienza University of Rome (Italy) - 2nd Faculty of Medicine, Sant' Andrea Hospital, Department of Anaesthesia and Critical Care Medicine |
- 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
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre, prospective, randomised, controlled, double-blinded study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Remifentanil-based general anaesthesia, oxygen, desflurane, buprenorphine, morphine |
| Primary outcome measure(s) |
Post-operative morphine consumption (PCA). |
| Key secondary outcome measure(s) |
1. Morphine titration at the end of the surgery |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
00189
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
