NCT02379780

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

February 19, 2015

Last Update Submit

March 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • anesthetic and opioid consumption during operation

    six months

Secondary Outcomes (2)

  • postoperative VAS scores

    six months

  • duration of analgesia

    six months

Study Arms (2)

USG guided Subcostal TAP block

ACTIVE COMPARATOR

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.

Procedure: USG guided Subcostal TAP blockProcedure: USG guided Paravertebral Block

USG guided Paravertebral Block

ACTIVE COMPARATOR

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.

Procedure: USG guided Subcostal TAP blockProcedure: USG guided Paravertebral Block

Interventions

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.

USG guided Paravertebral BlockUSG guided Subcostal TAP block

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.

USG guided Paravertebral BlockUSG guided Subcostal TAP block

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • ILKE KUPELI

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    PRINCIPAL INVESTIGATOR
  • ZEHRA BEDİR

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY CHAIR
  • HUSEYIN EKEN

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY CHAIR
  • UFUK KUYRUKLUYILDIZ

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY CHAIR
  • DIDEM ONK

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY CHAIR
  • ORHAN BINICI

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY CHAIR
  • AYSIN ALAGOL

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY DIRECTOR
  • GULDANE KARABAKAN

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist dr

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 5, 2015

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03