NCT02219542

Brief Summary

The investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

August 14, 2014

Last Update Submit

June 30, 2015

Conditions

Laparoscopic Colonic Surgery

Keywords

cytokine Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • The change of cytokine level in plasma samples

    The blood samples were collected before induction of anesthesia and at the end of surgery.

    just after anesthesia induction ; at the end of the surgery; 24h after surgery

Study Arms (2)

a standard general anesthesia

PLACEBO COMPARATOR

a standard general anesthesia and with transversus abdominis plane block 20 ml 0.9% sodium chloride

Drug: transversus abdominis plane block

transversus abdominis plane block

EXPERIMENTAL

a standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine

Drug: transversus abdominis plane block

Interventions

transversus abdominis plane blockDRUG

transversus abdominis plane block with 20 mL saline

a standard general anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were deemed eligible if they were candidates for spinal anesthesia undergoing Laparoscopic Colonic Surgery

You may not qualify if:

  • Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 (of the 30 possible points)
  • A history of neurological and psychiatric diseases including stroke, and psychosis
  • Severe visual or hearing impairment
  • Unwillingness to comply with the protocol or procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Study Officials

  • Hong Ma, M.D.,PhD

    The department of Anesthesiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate proffessor

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 19, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 1, 2015

Record last verified: 2014-05

Locations

CN(1)