Clinical Trials Directory

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UnknownNCT03403842

Acute Post-operative Pain in Colon Resections

Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
159 (estimated)
Sponsor
IRCCS San Raffaele · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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)

Conditions

Interventions

TypeNameDescription
DEVICESublingual sufentanil tablet systemAdministration of sublingual sufentanil with a PCA
DEVICEPeridural catheterPositioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg
DRUGPCA MorphineAdministration of endovenous morphine with a PCA

Timeline

Start date
2018-02-01
Primary completion
2019-08-01
Completion
2019-08-01
First posted
2018-01-19
Last updated
2019-02-07

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03403842. Inclusion in this directory is not an endorsement.