Analgesia
Conditions
Brief summary
Objective of the study is to compare three different analgesic techniques in patients undergoing laparoscopic colon resections: peridural catheter, patient controlled analgesia of endovenous morphine and patient controlled analgesia of sufentanil sublingual tablets.
Detailed description
159 patients undergoing laparoscopic colon resections will be enrolled and randomized in three different groups. Patients in the first group will be subjected to the positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2%99 ml+sufentanil 50 mcg at an infusion rate of 4-6 ml/h. In the second group participants will receive an intraoperative bolus of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of endovenous morphine (injection dose 1 mg,lock-out 10 minutes,maximum morphine dosage for hour 4 mg). In the third group the investigators will adopt an intraoperative bouls of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of sufentanil sublingual tablets( 15 mcg, lock-out 20 minutes)
Interventions
Administration of sublingual sufentanil with a PCA
DEVICEPeridural catheter
Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg
DRUGPCA Morphine
Administration of endovenous morphine with a PCA
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age\>18 Patients undergoing laparoscopic colon resections/ Acceptance informed consent
Exclusion criteria
* Contraindications to the positioning of a peridural catheter/ Previous allergic reactions to the drugs used in the study/ inability of using patient controlled analgesia system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity change in the post-operative period depending on the adopted analgesic treatment | NRS will be evaluated in recovery room at 30 minutes after the end of surgery and at 6-24-48-72 hours after the end of surgery or until to the end of the proposed analgesic treatment | The intensity of acute post-operative pain will be evaluated ,according NRS(numerical rating scale) by our Acute pain Service.NRS is a 11 point scale for patient self-reporting of pain, where zero represents no pain and ten is considered as the worst pain ever possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | The onset of possible side effects will be monitored from randomization until to the end of the proposed analgesic treatment, assessed up to 72 hours | Evaluation of possible side effects according to the technique adopted |
Countries
Italy
Contacts
Primary Contactstefano turi, md
Backup Contactmarco gemma, md
Outcome results
None listed