UMIN-CTR Clinical Trial

Public title

Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.

Acronym

RCT on PCEA vs iv-PCA for laparoscopic colorectomy within an enhanced recovery pathway

Scientific Title

Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.

Scientific Title:Acronym

RCT on PCEA vs iv-PCA for laparoscopic colorectomy within an enhanced recovery pathway

Region

Japan

Condition

Colon cancer

Classification by specialty

Gastrointestinal surgery

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masafumi Nakamura,MD

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Surgery and Oncology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5437

Email

mnaka@surg1.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tatsuya Manabe,MD

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Surgery and Oncology

Zip code

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

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Department of anesthesia in Kyushu University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

05

Month

16

Day

Date of IRB

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

Other related information

Registered date

2016

Year

10

Month

11

Day

Last modified on

2016

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027970