UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.
Title of the study (Brief title)	RCT on PCEA vs iv-PCA for laparoscopic colorectomy within an enhanced recovery pathway
Region	Japan

Condition
Condition	Colon cancer
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate a novel method for perioperative pain control by conducting a comparative study to assess the restorative efficacy of patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopic coloectomy within an enhanced recovery pathway
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Medical recovery defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion)
Key secondary outcomes	1.Time periods of anesthesia in preparation for and during surgery 2.Pain score (VAS) during the first to fifth postoperative day 3.Postoperative general status 4.Total dose of analgesic drug used for PCEA / iv-PCA 5.Frequency of additional analgesic drug use for pain control 6.Occurrence rate and severity of adverse effects 7.Postoperative hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pain control by epidural anesthesia with continuing administration of 0.125% levobupivacaine hydrochloride for 48 hours after surgery allowing the patient-controlled analgesia with bolus injection of 3ml of 0.125% levobupivacaine
Interventions/Control_2	Pain control by intravenous patient-controlled analgesia with continuing administration of fentanyl(0.3-0.5microg/kg/hr) for 48 hours after surgery allowing the patient-controlled analgesia with bolus injection(0.4-0.6microg/kg/bolus)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Colon cancer patients 2. Histologically proven adenocarcinoma of the rectum 3. Adequate organ function 4. Performance status (PS) 0-2 5. Indication for laparoscopic surgery 6. Written informed consent
Key exclusion criteria	1. Indication for laparotomy 2. Indication for combined resection 3. Emergency case 4. With high risk factors for treatment delay of wound (active infection, uncontrolled diabetes mellitus, severe renal dysfunction, usage of immunosuppressive agent ) 5. Contraindication of PCEA 6. Contraindication of iv-PCA 7. Common use with drugs affecting pain control 8. With interstitial lung disease or pulmonary fibrosis 9. Pregnant 10. Patients who do not give written informed consent.
Target sample size	110

Research contact person
Name of lead principal investigator	Masafumi Nakamura,MD
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Surgery and Oncology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5437
Email	mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tatsuya Manabe,MD
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Surgery and Oncology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5440
Homepage URL
Email	manabe@surg1.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of anesthesia in Kyushu University
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 11 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 16 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2016 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027970