Acute Post-operative Pain in Colon Resections (ERAS-PO)

San Donato Group (GSD)

Status: Unknown

Conditions: Analgesia

Treatments: Drug: PCA Morphine; Device: Peridural catheter; Device: Sublingual sufentanil tablet system

Study type: Interventional

Funder types: Other

Identifiers

NCT03403842

125/INT/2017

Details and patient eligibility

About

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.

Full 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)

Enrollment: 159 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

PERIDURAL

Active Comparator group

Description:

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

Treatment:

Device: Peridural catheter

PCA MORPHINE

Active Comparator group

Description:

Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg

Treatment:

Drug: PCA Morphine

SSTS

Experimental group

Description:

Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes

Treatment:

Device: Sublingual sufentanil tablet system