UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028240 |
|---|---|
| Receipt number | R000032133 |
| Scientific Title | Phase II clinical trial of multimodal analgesia for postoperative pain management in patients undergoing laparoscopic colorectal resection for cancer |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2025/01/18 11:03:19 |
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Basic information
Public title
Phase II clinical trial of multimodal analgesia for postoperative pain management in patients undergoing laparoscopic colorectal resection for cancer
Acronym
Phase II clinical trial of multimodal analgesia in patients undergoing laparoscopic colorectal resection
Scientific Title
Phase II clinical trial of multimodal analgesia for postoperative pain management in patients undergoing laparoscopic colorectal resection for cancer
Scientific Title:Acronym
Phase II clinical trial of multimodal analgesia in patients undergoing laparoscopic colorectal resection
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Anesthesiology |
| Operative medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the use of a multimodal analgesia in patients undergoing laparoscopic colorectal resection for cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative stay
Key secondary outcomes
Pain score (NRS,PRS), postoperative complications, frequency of PCA, time to walk, time to food intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Multimodal analgesia
Interventions/Control_2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
# Pathologically proven carcinoma.
# Primary tumor located at colon or upper rectum
# Rectal cancers of which the lower border is located below the peritoneal reflection are excluded.
# Aged 20 to 85 years old
# Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
# Written informed consent
Key exclusion criteria
# Allergy to any drugs used in this trial
Distant metastases
# Interstitial pneumonia or fibroid lung.
# Uncontrolled diabetes mellitus.
# Uncontrolled hypertension
# Uncontrolled urinary disorder
# Unable to provide informed consent
# Those considered inappropriate for participation in this trial.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Kawamura |
Organization
Kindai University
Division name
Surgery
Zip code
589-8511
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL
072-366-0221
kawamuraj@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shohko |
| Middle name | |
| Last name | Matsukawa |
Organization
Kindai University
Division name
Surgery
Zip code
589-8511
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL
072-366-0221
Homepage URL
profsec-matsukawa@surg.med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
Department of Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Hospital IRB
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
| 2017 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000032133&t
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000032133&t
Number of participants that the trial has enrolled
48
Results
The mean postoperative hospital stay was 9.00 days (95% CI = 8.19 to 9.39, p < 0.0001). There were relatively high NRS and PRS scores from postoperative (POD) 0-1, which subsequently decreased and reach their lowest value at POD 4-5. Nausea and vomiting were observed in 17 (42.5%) and 12 (30.0%) patients, respectively.
Results date posted
| 2025 | Year | 01 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled patients undergoing laparoscopic surgery for colorectal cancer at our hospital between September 2017 and August 2018.
Participant flow
We registered 48 patients; among them, 40 patients were eligible.
Adverse events
Nausea and vomiting occurred in 17 (42.5%) and 12 (30.0%) patients, respectively. Three (7.5%) patients discontinued IV-PCA due to nausea and vomiting. Liver dysfunction occurred in 7 (17.5%) patients with increased aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels with all of them recovering rapidly. One (2.5%) patient presented with lower gastrointestinal bleeding. There were no serious postoperative complications, including dysuria, respiratory depression, hypotension, allergic reactions, and asthma attacks.
Outcome measures
Postoperative hospital stay
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032133
