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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219542
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Colonic Surgery Drug: transversus abdominis plane block Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cytokines of Patients After Laparoscopic Colonic Surgery
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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

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 0.25% ropivacaine




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219542


Locations
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China, Liaoning
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
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Study Chair: Hong Ma, M.D.,PhD The department of Anesthesiology
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Responsible Party: Wen-fei Tan, Associate proffessor, China Medical University, China
ClinicalTrials.gov Identifier: NCT02219542    
Other Study ID Numbers: 20140804
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: May 2014
Keywords provided by Wen-fei Tan, China Medical University, China:
cytokine Transversus Abdominis Plane Block