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Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy

Primary Purpose

Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
USG guided Subcostal TAP block
USG guided Paravertebral Block
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18-65 years of age,
  • ASA I-II-III
  • laparoscopic cholecystectomy to be applied

Exclusion Criteria:

  • patient refusal
  • mental and psychiatric disorders,
  • allergy history of the drug to be used,
  • kyphoscoliotic anatomical disorder
  • patients with coagulopathies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    USG guided Subcostal TAP block

    USG guided Paravertebral Block

    Arm Description

    after preparing the skin, ultrasound probe was placed obliquely on the upper abdominal wall along the subcostal margin near the midline. the rectus abdominis muscles, transversus abdominis muscles and the fascial plane (TAP) between rectus abdominis and transversus abdominis muscles were identified. after identification, the block needle was introduced anteriorly in the plane of the ultrasound beam. the needle was directed the transversus abdominis plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.

    prior to start surgery, was performed in the left lateral position. after preparing skin, ultrasound linear probe was placed, 2-3 cm lateral of the T7 / T8 level in the midline. After determining the transverse process and ribs as hyperechoic, the paravertebral space was identified as an area wedge-shaped bounded by the pleura and above the internal intercostal membrane.after identification of the paravertebral space, the block needle was introduced in plane / out of plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.

    Outcomes

    Primary Outcome Measures

    anesthetic and opioid consumption during operation

    Secondary Outcome Measures

    postoperative VAS scores
    duration of analgesia

    Full Information

    First Posted
    February 19, 2015
    Last Updated
    March 5, 2015
    Sponsor
    Cukurova University
    Collaborators
    Erzincan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379780
    Brief Title
    Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy
    Official Title
    Comparison of the Effects of Perioperative Anesthesia Consumption of Ultrasound Guided Subcostal Transversus Abdominis Plane and Paravertebral Block in Laparoscopic Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cukurova University
    Collaborators
    Erzincan University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators aimed to compare the effects of perioperative anesthesia consumption of ultrasound guided subcostal transversus abdominis plane and paravertebral block in laparoscopic cholecystectomy.
    Detailed Description
    Fifty patients aged 18 - 65 years, American Society of Anesthesiologists (ASA) I-II-III, scheduled for laparoscopic cholecystectomy were enrolled into the study. Patients were allocated into two groups to receive ultrasound guided subcostal transversus abdominis plane block (group T, n=25) or ultrasound guided paravertebral block (group P, n=25). In all patients; anesthesia was induced with iv propofol (2 mg.kg-1) and maintained with total intravenous anesthesia (TIVA) in a mixture of 50 % nitrous oxide and 50 % oxygen with a total gas flow rate of 4 L min-1. Neuromuscular relaxation was induced with iv rocuronium (0.5 mg.kg-1). Propofol (2 mg / cc, 2-4 mg / kg / h) and remifentanil (13.3 mcg / cc, 1-3 mcg / kg / h) combination was used in TIVA. Propofol and remifentanil rates increased or reduced according to the patient's hemodynamic response. Prior to start surgery, ultrasound guided subcostal transversus abdominis plane or paravertebral block was performed in patients . Blood pressure, heart rate and peripheral oxygen saturation,TIVA consumption of 0, 5, 10, 15, 30, 60 min were recorded for all patients.Before the end of surgery, tramadol was administered (2 mg / kg) for all patients. All patients were evaluated at postoperative 2th, 4th, 8th, 12th, 24th hours with; operation time, heart rate, blood pressure, peripheral oxygen saturation, visual pain scores (VAS), analgesic consumption, complications (hypotension, anaphylaxis, hematoma, IV injection, intra-abdominal organ injury, pneumothorax ) and patient satisfaction status were recorded. In the postoperative period if there is additional analgesic requirements (VAS≥4) tramadol 2 mg.kg-1 was administered as IV. The first hour is needed analgesia were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholecystitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    USG guided Subcostal TAP block
    Arm Type
    Active Comparator
    Arm Description
    after preparing the skin, ultrasound probe was placed obliquely on the upper abdominal wall along the subcostal margin near the midline. the rectus abdominis muscles, transversus abdominis muscles and the fascial plane (TAP) between rectus abdominis and transversus abdominis muscles were identified. after identification, the block needle was introduced anteriorly in the plane of the ultrasound beam. the needle was directed the transversus abdominis plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.
    Arm Title
    USG guided Paravertebral Block
    Arm Type
    Active Comparator
    Arm Description
    prior to start surgery, was performed in the left lateral position. after preparing skin, ultrasound linear probe was placed, 2-3 cm lateral of the T7 / T8 level in the midline. After determining the transverse process and ribs as hyperechoic, the paravertebral space was identified as an area wedge-shaped bounded by the pleura and above the internal intercostal membrane.after identification of the paravertebral space, the block needle was introduced in plane / out of plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.
    Intervention Type
    Procedure
    Intervention Name(s)
    USG guided Subcostal TAP block
    Intervention Description
    Ultrasonography Assisted Subcostal TAP blockage: In plane technique was applied and 22 G needle (BRAUN Stimuplex D Plus 0,71*50 mm 22G*2) was used. Intravascular injection was eliminated after the passage of rectus sheath by negative aspiration. 0,5-1 ml local anesthetic was applied directly to confirm the right place. 10 cc bupivacain ( 0,5 % Marcain flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site. The same procedure was applied to the opposite site. we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.
    Intervention Type
    Procedure
    Intervention Name(s)
    USG guided Paravertebral Block
    Intervention Description
    Ultrasonoraphy assisted Thoracic Paravertebral blockage application: In-plane or out-of-plane technique was used with stimuplex needle (BRAUN Stimuplec D Plus 0,71*50 mm 22 G* 2'', 15°). Popping sensation that was felt by the penetration of the internal intercostal membrane, guided to paravertebral space. Intravascular injection was eliminated by negative aspiration. 0,5 - 1 ml local anesthetic injection was administered to show the displacement of pleura downward that confirmed the place of the needle in the right place. Then 10 cc bupivacain (% 0.5 Marcaine® flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site. we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.
    Primary Outcome Measure Information:
    Title
    anesthetic and opioid consumption during operation
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    postoperative VAS scores
    Time Frame
    six months
    Title
    duration of analgesia
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Between 18-65 years of age, ASA I-II-III laparoscopic cholecystectomy to be applied Exclusion Criteria: patient refusal mental and psychiatric disorders, allergy history of the drug to be used, kyphoscoliotic anatomical disorder patients with coagulopathies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ILKE KUPELI
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    ZEHRA BEDİR
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    HUSEYIN EKEN
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    UFUK KUYRUKLUYILDIZ
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    DIDEM ONK
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    ORHAN BINICI
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    AYSIN ALAGOL
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    GULDANE KARABAKAN
    Organizational Affiliation
    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18227342
    Citation
    Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.
    Results Reference
    result
    PubMed Identifier
    14570678
    Citation
    Williams SR, Chouinard P, Arcand G, Harris P, Ruel M, Boudreault D, Girard F. Ultrasound guidance speeds execution and improves the quality of supraclavicular block. Anesth Analg. 2003 Nov;97(5):1518-1523. doi: 10.1213/01.ANE.0000086730.09173.CA.
    Results Reference
    result
    PubMed Identifier
    7710020
    Citation
    Cheema SP, Ilsley D, Richardson J, Sabanathan S. A thermographic study of paravertebral analgesia. Anaesthesia. 1995 Feb;50(2):118-21. doi: 10.1111/j.1365-2044.1995.tb15092.x.
    Results Reference
    result
    PubMed Identifier
    19376789
    Citation
    El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
    Results Reference
    result
    PubMed Identifier
    19574864
    Citation
    Ozkan D, Akkaya T, Comert A, Balkc N, Ozdemir E, Gumus H, Ergul Z, Kaya O. Paravertebral block in inguinal hernia surgeries: two segments or 4 segments? Reg Anesth Pain Med. 2009 Jul-Aug;34(4):312-5. doi: 10.1097/AAP.0b013e3181ae1169.
    Results Reference
    result
    PubMed Identifier
    22622954
    Citation
    Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24.
    Results Reference
    result
    PubMed Identifier
    20448076
    Citation
    Thavaneswaran P, Rudkin GE, Cooter RD, Moyes DG, Perera CL, Maddern GJ. Brief reports: paravertebral block for anesthesia: a systematic review. Anesth Analg. 2010 Jun 1;110(6):1740-4. doi: 10.1213/ANE.0b013e3181da82c8. Epub 2010 May 6.
    Results Reference
    result
    PubMed Identifier
    21177284
    Citation
    Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.
    Results Reference
    result

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    Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy

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