Intrathecal Morphine Analgesia vs. Continuous Epidural Analgesia vs. Systemic Analgesia in Colorectal Surgery.

NCT03007121 | Completed Phase 4

• 1 other identifier: KOLORIT1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine which postoperative analgesia is optimal after colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural analgesia and standard systemic analgesia. All patients will have the possibility to administer themselves intravenous morphine as needed.

Conditions

Analgesia, Patient-Controlled; Epidural Analgesia; Anesthesia; Spinal; Morphine; Surgery, Colorectal; Intravenous Drug Delivery Systems

Outcome Measures

Primary Outcomes (2)

• Non-inferiority of analgesia with intrathecal morphine 0.3mg compared with epidural mixture bupivacaine 0.125% and sufentanil 0,4ug/ml.

  Non-interiority is defined as difference in morphine consumption during patient-controlled analgesia no more than 10%

  Within the first 3 days after surgery

• Better analgesia after intrathecal morphine compared to systemic analgesia with morphine

  Lower consumption of PCA morphine in patients with intrathecal morphine compared to systemic analgesia with PCA morphine only.

  Within the first 3 days after surgery

Secondary Outcomes (2)

• Side effects of intrathecal morphine compared to epidural or systemic analgesia

  Within the first 3 days after surgery

• Pain intensity

  Within the first 3 days after surgery

Study Arms (3)

Morphine intrathecal

EXPERIMENTAL

An intrathecal administration of preservative-free morphine 0.3 mg in 3 ml NS prepared in a sterile ampoules by a hospital pharmacy will be performed before induction of anaesthesia in a sitting position between L2 and L3 - L4/L5 vertebrae. Standard general anaesthesia will be performed. After surgery, the patients will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out interval 5 min for 3 days at a surgical ICU.

Drug: Morphine intrathecal; Drug: Morphine intravenous

Bupivacaine + Sufentanil epidural

ACTIVE COMPARATOR

An epidural catheter will be inserted before induction of anaesthesia in a sitting position between T9 and T10 - T12 and L1 vertebrae. A test dose of 4 ml 0.5 bupivacaine will be administered to rule out intravascular injection or subarachnoid or subdural block. Standard general anaesthesia will be performed. Thirty minutes before the end of the surgery, patients will be administered a bolus of a mixture of bupivacaine 0.5% (3 ml) + sufentanil 10 mcg (2 ml) + NS 5 ml followed by a continuous infusion of a mixture containing in 1 ml bupivacaine 0,125% and sufentanil 0,4 mcg at 8 ml/h. At the same time patients will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out interval 5 min for 3 days at a surgical ICU.

Drug: Bupivacaine + Sufentanil epidural; Drug: Morphine intravenous

Morphine intravenous

ACTIVE COMPARATOR

Patients will be administered standard general anaesthesia. After surgery, bolus doses of morphine 2 mg will be administered until level of pain will be \< 4 (VAS 0 - 10). Analgesia will be continued by PCA device using morphine, bolus dose 1 mg, lock-out interval 5 min. for 3 days at surgical ICU.

Drug: Morphine intravenous

Interventions

Morphine intrathecal DRUG

Administration of intrathecal injection of 0.3 mg preservative-free morphine in 3 ml NS

Also known as: Morphine spinal

Morphine intrathecal

Bupivacaine + Sufentanil epidural DRUG

Continuous epidural infusion of a mixture containing in 1 ml bupivacaine 0,125% and sufentanil 0,4 mcg at 8 ml/h.

Also known as: Epidural analgesia with bupivacaine and sufentanil

Bupivacaine + Sufentanil epidural

Morphine intravenous DRUG

Patiernt-controlled i.v. analgesia with morphine

Also known as: Morphine and patient controlled analgesia

Bupivacaine + Sufentanil epidural; Morphine intrathecal; Morphine intravenous

Eligibility Criteria

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

You may qualify if:

• Patients with elective colorectal surgery (left or right hemicolectomy, subtotal colectomy, resection of sigmoid, rectal or cecum)

You may not qualify if:

• Known allergy to any of drugs used, coagulopathy, sepsis, cognitive dysfunction and/or inability to understand instruction.
• Pregnancy (is assessed as a part of pre-operative examination).
• Abuse of drugs or morphine therapy before surgery.
• Idiopathic bowel disease.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

Related Publications (13)

• Devys JM, Mora A, Plaud B, Jayr C, Laplanche A, Raynard B, Lasser P, Debaene B. Intrathecal + PCA morphine improves analgesia during the first 24 hr after major abdominal surgery compared to PCA alone. Can J Anaesth. 2003 Apr;50(4):355-61. doi: 10.1007/BF03021032. English, French.

  PMID: 12670812 BACKGROUND

• Beaussier M, Weickmans H, Parc Y, Delpierre E, Camus Y, Funck-Brentano C, Schiffer E, Delva E, Lienhart A. Postoperative analgesia and recovery course after major colorectal surgery in elderly patients: a randomized comparison between intrathecal morphine and intravenous PCA morphine. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):531-8. doi: 10.1016/j.rapm.2006.06.250.

  PMID: 17138196 BACKGROUND

• Sakowska M, Docherty E, Linscott D, Connor S. A change in practice from epidural to intrathecal morphine analgesia for hepato-pancreato-biliary surgery. World J Surg. 2009 Sep;33(9):1802-8. doi: 10.1007/s00268-009-0131-2.

  PMID: 19548026 BACKGROUND

• Virlos I, Clements D, Beynon J, Ratnalikar V, Khot U. Short-term outcomes with intrathecal versus epidural analgesia in laparoscopic colorectal surgery. Br J Surg. 2010 Sep;97(9):1401-6. doi: 10.1002/bjs.7127.

  PMID: 20603849 BACKGROUND

• Levy BF, Scott MJ, Fawcett W, Fry C, Rockall TA. Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery. Br J Surg. 2011 Aug;98(8):1068-78. doi: 10.1002/bjs.7545. Epub 2011 May 17.

  PMID: 21590762 BACKGROUND

• Werawatganon T, Charuluxananan S. WITHDRAWN: Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD004088. doi: 10.1002/14651858.CD004088.pub3.

  PMID: 23543529 BACKGROUND

• Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.

  PMID: 11118174 BACKGROUND

• Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.

  PMID: 11965272 BACKGROUND

• Manion SC, Brennan TJ. Thoracic epidural analgesia and acute pain management. Anesthesiology. 2011 Jul;115(1):181-8. doi: 10.1097/ALN.0b013e318220847c. No abstract available.

  PMID: 21606825 BACKGROUND

• Moen V, Dahlgren N, Irestedt L. Severe neurological complications after central neuraxial blockades in Sweden 1990-1999. Anesthesiology. 2004 Oct;101(4):950-9. doi: 10.1097/00000542-200410000-00021.

  PMID: 15448529 BACKGROUND

• Meylan N, Elia N, Lysakowski C, Tramer MR. Benefit and risk of intrathecal morphine without local anaesthetic in patients undergoing major surgery: meta-analysis of randomized trials. Br J Anaesth. 2009 Feb;102(2):156-67. doi: 10.1093/bja/aen368.

  PMID: 19151046 BACKGROUND

• De Pietri L, Siniscalchi A, Reggiani A, Masetti M, Begliomini B, Gazzi M, Gerunda GE, Pasetto A. The use of intrathecal morphine for postoperative pain relief after liver resection: a comparison with epidural analgesia. Anesth Analg. 2006 Apr;102(4):1157-63. doi: 10.1213/01.ane.0000198567.85040.ce.

  PMID: 16551916 BACKGROUND

• Holte K, Kehlet H. Epidural analgesia and risk of anastomotic leakage. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):111-7. doi: 10.1053/rapm.2001.21241.

  PMID: 11251133 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Analgesia, Epidural; Sufentanil; Morphine; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jiri Malek, M.D.

  3rd Medical Faculty, Charles University and University Hiospital Kralovske Vinohrady

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD, Ph.D.

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 2, 2017
• Study Start: April 10, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 17, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)