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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007121
Other study ID # KOLORIT1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 10, 2017
Est. completion date December 17, 2018

Study information

Verified date January 2019
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine intrathecal
Administration of intrathecal injection of 0.3 mg preservative-free morphine in 3 ml NS
Bupivacaine + Sufentanil epidural
Continuous epidural infusion of a mixture containing in 1 ml bupivacaine 0,125% and sufentanil 0,4 mcg at 8 ml/h.
Morphine intravenous
Patiernt-controlled i.v. analgesia with morphine

Locations

Country Name City State
Czechia University Hospital Kralovske Vinohrady Praha

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (13)

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Outcome

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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