Acute Post-operative Pain in Colon Resections

Analgesia Clinical Trial

— ERAS-PO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03403842
• Other study ID #: 125/INT/2017
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: February 2019
• Source: IRCCS San Raffaele
• Contact: stefano turi, md
• Phone: 0226432656
• Email: turi.stefano[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative

Intervention

Device:
• Sublingual sufentanil tablet system
Administration of sublingual sufentanil with a PCA
• Peridural catheter
Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg

Drug:
• PCA Morphine
Administration of endovenous morphine with a PCA

Locations

Country	Name	City	State
Italy	S. Raffaele Hospital	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. Review. — View 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. Review. — View 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, Ytrebø 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. Review. — View 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. Review. — View 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28. Review. — View Citation

Hübner 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects	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