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

Primary Purpose

Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sublingual sufentanil tablet system
Peridural catheter
PCA Morphine
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • S. Raffaele HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

PERIDURAL

PCA MORPHINE

SSTS

Arm 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

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

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

Outcomes

Primary Outcome Measures

Pain intensity change in the post-operative period depending on the adopted 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

Side effects
Evaluation of possible side effects according to the technique adopted

Full Information

First Posted
December 29, 2017
Last Updated
February 5, 2019
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03403842
Brief Title
Acute Post-operative Pain in Colon Resections
Acronym
ERAS-PO
Official Title
Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PERIDURAL
Arm Type
Active Comparator
Arm 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
Arm Title
PCA MORPHINE
Arm Type
Active Comparator
Arm Description
Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg
Arm Title
SSTS
Arm Type
Experimental
Arm Description
Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes
Intervention Type
Device
Intervention Name(s)
Sublingual sufentanil tablet system
Other Intervention Name(s)
Zalviso
Intervention Description
Administration of sublingual sufentanil with a PCA
Intervention Type
Device
Intervention Name(s)
Peridural catheter
Intervention Description
Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg
Intervention Type
Drug
Intervention Name(s)
PCA Morphine
Intervention Description
Administration of endovenous morphine with a PCA
Primary Outcome Measure Information:
Title
Pain intensity change in the post-operative period depending on the adopted analgesic treatment
Description
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
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
Secondary Outcome Measure Information:
Title
Side effects
Description
Evaluation of possible side effects according to the technique adopted
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stefano turi, md
Phone
0226432656
Email
turi.stefano@hsr.it
First Name & Middle Initial & Last Name or Official Title & Degree
marco gemma, md
Phone
0226432656
Email
gemma.marco@hsr.it
Facility Information:
Facility Name
S. Raffaele Hospital
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Gemma, MD
Phone
++390226432656
Email
gemma.marco@hsr.it
First Name & Middle Initial & Last Name & Degree
stefano turi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26514824
Citation
Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30.
Results Reference
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PubMed Identifier
27642630
Citation
Borzellino G, Francis NK, Chapuis O, Krastinova E, Dyevre V, Genna M. Role of Epidural Analgesia within an ERAS Program after Laparoscopic Colorectal Surgery: A Review and Meta-Analysis of Randomised Controlled Studies. Surg Res Pract. 2016;2016:7543684. doi: 10.1155/2016/7543684. Epub 2016 Aug 24.
Results Reference
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PubMed Identifier
25119117
Citation
Hubner M, Blanc C, Roulin D, Winiker M, Gander S, Demartines N. Randomized clinical trial on epidural versus patient-controlled analgesia for laparoscopic colorectal surgery within an enhanced recovery pathway. Ann Surg. 2015 Apr;261(4):648-53. doi: 10.1097/SLA.0000000000000838.
Results Reference
background
PubMed Identifier
23099039
Citation
Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
Results Reference
background
PubMed Identifier
21154380
Citation
Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
Results Reference
background
PubMed Identifier
28097305
Citation
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
Results Reference
background
PubMed Identifier
27067596
Citation
Frampton JE. Sublingual Sufentanil: A Review in Acute Postoperative Pain. Drugs. 2016 Apr;76(6):719-29. doi: 10.1007/s40265-016-0571-6.
Results Reference
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Acute Post-operative Pain in Colon Resections

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