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CompletedNCT04634721Updated Jan 28, 2021

Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

An interventional study of bupivacaine in Bupivacaine, Anesthetics, Local and Anesthetics, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Abdominal wall blocks are frequently used as part of multimodal analgesia for pain control after abdominal surgery. There are studies using the Transversus Abdominis Plane Block for postoperative pain control in laparoscopic cholecystectomies.

In this study, the investigators aimed to compare the advantages of these two methods by applying the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy with the help of postoperative USG and laparoscopy during surgery.In this study, the investigators aimed to compare the advantages of these two methods by applying the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy with the help of postoperative USG and LAPAROSCOPY during surgery.

Read the detailed description

A total of 60 patients aged 18-65, ASA 1-2-3, who will undergo elective laparoscopic cholecystectomy in our hospital, will be included in the study. Patients will be randomly divided into 3 groups with ultrasound (USG) guided (GROUP 1: USG) , Laparoscopic application (GROUP 2: LAP) and GROUP 3 :No-TAP blok Each group consists of 20 evil people. Written consent will be obtained by explaining the procedure to be performed before the operation to the patients. The Transversus Abdominis Plan Block will be applied to the patients by a blind anesthesiologist according to their group. The block to be made by the anesthesiologist who will apply the block procedure will be given in a closed envelope.

02

Conditions studied

  • Bupivacaine
  • Anesthetics, Local
  • Anesthetics
  • Peripheral Nervous System Agents

Keywords

  • TAP block
  • laparoscopy
  • laparoscopic cholecystectomy
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 437 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ASA I,II,III
  • Patients 18-65
  • laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • ASA III higher
  • history of pain relief medication dependence
  • history of substance abuse
  • end stage chronic kidney disease
  • advanced liver disease
  • history of chronic pain -history of taking opioids or neuropathic agents regularly prior to surgery-
  • BMI of 50 or over
  • skin infections at the site of TAP block injection or port sites.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Laparoscopic TAP block

    Laparoscopic assisted TAP block will be done by surgeon intra-operatively

    Drug: bupivacaine

  • Active comparator
    Ultrasaund TAP block

    injecting bupivacaine in transversus abdominis plane to block the somatic nerves

    Drug: bupivacaine

  • No intervention
    no TAP block

    no TAP block would be done

Interventions

  • In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine injected . This will then be repeated on the contralateral side.

06

What researchers measure

Primary outcomes

  1. Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours

    o compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between three groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)

    Time frame: 24 hours

Secondary outcomes

  1. Post operative nausea or vomiting

    instances of nausea or vomiting in the post operative period will be recorded

    Time frame: 24 hours

Other outcomes

  1. Total opioid usage

    amount of opioids used in perioperative period will be recorded

    Time frame: 24 hours

07

Study locations

1 site
  • Ankara Şehir Hastanesi
    Ankara, Çankaya, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04634721
Responsible party
Mehmet sahap (Principal Investigator, Ankara City Hospital Bilkent) — Principal investigator
First posted
Nov 18, 2020
Start date
Nov 1, 2020
Primary completion
Dec 15, 2020
Completion
Jan 15, 2021
Last update
Jan 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bupivacaine

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