NCT02012244

Brief Summary

The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

December 7, 2013

Last Update Submit

January 10, 2016

Conditions

Colorectal Surgery

Keywords

analgesia; colorectal surgery; immunity; local anesthetics; opioids

Outcome Measures

Primary Outcomes (2)

  • NK cell activity

    NK cell activity : preoperation, POD 1, POD 2

    48 hours

  • IL-2

    IL-2 level : preoperation, POD 1, POD 2

    48 hours

Secondary Outcomes (1)

  • Complication and recurrence

    1 year

Other Outcomes (1)

  • Inflammatory responses

    48 hours

Study Arms (2)

fentanyl-based analgesia

EXPERIMENTAL

fentanyl intravenous patient-controlled analgesia + additional pethidine

Drug: fentanyl-based analgesia

local anesthetic wound infiltration-based anlagesia

EXPERIMENTAL

continuous wound inflitration with ropivacaine + tramadol intravenous patient-controlled analgesia + additional ketorolac or propacetamol

Drug: local anesthetic wound infiltration-based anlagesia

Interventions

fentanyl-based analgesiaDRUG

fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour

fentanyl-based analgesia
local anesthetic wound infiltration-based anlagesiaDRUG

continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour

local anesthetic wound infiltration-based anlagesia

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-III
  • years old
  • elective laparoscopic colorectal surgery for cancer

You may not qualify if:

  • drug allergy
  • significant renal or hepatic impairment
  • sign of infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Sedoul, South Korea

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 7, 2013

First Posted

December 16, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

KR(1)