Acute Post-operative Pain in Colon Resections

NCT03403842 | Unknown DMC

• 1 other identifier: 125/INT/2017
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• 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

Study Arms (3)

PERIDURAL

ACTIVE COMPARATOR

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

PCA MORPHINE

ACTIVE COMPARATOR

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

Drug: PCA Morphine

SSTS

EXPERIMENTAL

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

Device: Sublingual sufentanil tablet system

Interventions

Sublingual sufentanil tablet system DEVICE

Administration of sublingual sufentanil with a PCA

Also known as: Zalviso

SSTS

Peridural catheter DEVICE

Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg

PERIDURAL

PCA Morphine DRUG

Administration of endovenous morphine with a PCA

PCA MORPHINE

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 Patients undergoing laparoscopic colon resections/ Acceptance informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

S. Raffaele Hospital

Milan, MI, 20132, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 26514824 BACKGROUND

• 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.

  PMID: 27642630 BACKGROUND

• 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.

  PMID: 25119117 BACKGROUND

• 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.

  PMID: 23099039 BACKGROUND

• 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.

  PMID: 21154380 BACKGROUND

• 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.

  PMID: 28097305 BACKGROUND

• Frampton JE. Sublingual Sufentanil: A Review in Acute Postoperative Pain. Drugs. 2016 Apr;76(6):719-29. doi: 10.1007/s40265-016-0571-6.

  PMID: 27067596 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

stefano turi, md

CONTACT

0226432656; turi.stefano@hsr.it

marco gemma, md

CONTACT

0226432656; gemma.marco@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 19, 2018
• Study Start: February 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

IT (1)