Acute Post-operative Pain in Colon Resections

Not Applicable

• Conditions: Analgesia
• Interventions: Device: Peridural catheter; Drug: PCA Morphine; Device: Sublingual sufentanil tablet system

• Registration Number: NCT03403842
• Lead Sponsor: IRCCS San Raffaele

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)

Study Timeline

• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-19
• Study Start: 2018-02-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-07
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PERIDURAL	Peridural catheter	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
PCA MORPHINE	PCA Morphine	Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg
SSTS	Sublingual sufentanil tablet system	Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

S. Raffaele Hospital; 🇮🇹 Milano, MI, Italy