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

February 5, 2019 updated by: Marco Gemma, IRCCS San Raffaele

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • Recruiting
        • S. Raffaele Hospital
        • Principal Investigator:
          • stefano turi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Device: Peridural catheter
Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg
ACTIVE_COMPARATOR: PCA MORPHINE
Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg
Drug: PCA Morphine
Administration of endovenous morphine with a PCA
EXPERIMENTAL: SSTS
Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes
Device: Sublingual sufentanil tablet system
Administration of sublingual sufentanil with a PCA
Other Names:
  • Zalviso

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125/INT/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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