Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections
Overview
- Phase
- Not Applicable
- Intervention
- Peridural catheter
- Conditions
- Analgesia
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Pain intensity change in the post-operative period depending on the adopted analgesic treatment
- Last Updated
- 7 years ago
Overview
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)
Investigators
Marco Gemma
Principal Investigator
IRCCS San Raffaele
Eligibility Criteria
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
Arms & Interventions
PERIDURAL
Peridural catheter positioning with a continuous infusion of ropivacaine 0,2% 99 ml+ sufentanil 50 mcg at an infusion rate of 4-6 ml/h
Intervention: Peridural catheter
PCA MORPHINE
Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg
Intervention: PCA Morphine
SSTS
Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes
Intervention: Sublingual sufentanil tablet system
Outcomes
Primary Outcomes
Pain intensity change in the post-operative period depending on the adopted analgesic treatment
Time Frame: 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 Outcomes
- 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)