Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery

June 30, 2015 updated by: Wen-fei Tan, China Medical University, China

Cytokines of Patients After Laparoscopic Colonic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • •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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: a standard general anesthesia
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 with 20 mL saline
Drug: transversus abdominis plane block
transversus abdominis plane block with 20 mL 0.25% ropivacaine
Experimental: transversus abdominis plane block
a standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine
Drug: transversus abdominis plane block
transversus abdominis plane block with 20 mL saline
Drug: transversus abdominis plane block
transversus abdominis plane block with 20 mL 0.25% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of cytokine level in plasma samples
Time Frame: just after anesthesia induction ; at the end of the surgery; 24h after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Investigators

  • Study Chair: Hong Ma, M.D.,PhD, The department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20140804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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