Morphine Clinical Trial
— KOLORITOfficial title:
Comparison of Intrathecal Morphine, Epidural Bupivacaine With Sufentanil and Systemic Patient Controlled Analgesia With Morphine for Analgesia After Colorectal Surgery: Prospective Randomised Study.
Verified date | January 2019 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 17, 2018 |
Est. primary completion date | December 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with elective colorectal surgery (left or right hemicolectomy, subtotal colectomy, resection of sigmoid, rectal or cecum) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Kralovske Vinohrady | Praha |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic |
Czechia,
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. — View Citation
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. — View Citation
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. English, French. — View Citation
Holte K, Kehlet H. Epidural analgesia and risk of anastomotic leakage. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):111-7. — View Citation
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. — View Citation
Manion SC, Brennan TJ. Thoracic epidural analgesia and acute pain management. Anesthesiology. 2011 Jul;115(1):181-8. doi: 10.1097/ALN.0b013e318220847c. Review. — View Citation
Meylan N, Elia N, Lysakowski C, Tramèr 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. Review. — View Citation
Moen V, Dahlgren N, Irestedt L. Severe neurological complications after central neuraxial blockades in Sweden 1990-1999. Anesthesiology. 2004 Oct;101(4):950-9. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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;(3):CD004088. doi: 10.1002/14651858.CD004088.pub3. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Side effects of intrathecal morphine compared to epidural or systemic analgesia | Number of patients with respiratory rate <8/min, SpO2<90%, changes of blood pressure and pulse rate > 30% above base level before surgery, episodes of postoperative nausea and vomiting, interval since surgery to the first bowel movement confirmed by auscultation and interval to the first flatus. | Within the first 3 days after surgery | |
Secondary | Pain intensity | Area below visual analogue scale (0 - 10) pain intensity after 72 hours | Within the first 3 days after surgery |
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