NCT04767542

Brief Summary

Patients with acute cholecystitis or pancreatitis due to gallstones benefit from emergency laparoscopic cholecystectomy (LC). Patients with emergency LC show improvement in their quality of life within one month compared to those treated. Delayed LC (after the acute phase has passed and recovered) and less time to work. This strategy reduces the risk of repeated admissions with more pain or pancreatitis. There are many studies on the effectiveness of the Elective LC and Transversus Abdominis Plan (TAP) Block on pain. However, a prospective study on the reduction of postoperative pain with emergency LC and TAP Block has not been carried out until now. This study will be conducted to evaluate the effectiveness of the TAP Block in patients undergoing emergency LC.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_3

Status
unknown

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

First Submitted

Initial submission to the registry

February 5, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

February 5, 2021

Last Update Submit

March 2, 2021

Conditions

Transversus Abdominis Plane (TAP) Block

Keywords

acute cholecystitispostoperative paintransversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Postoperative Verbal Rating Score and Visuale analogue scoring will be done.

    Preoperative 1th hour

Secondary Outcomes (5)

  • Pain Score

    Postoperative 1st hour

  • Pain Score

    Postoperative 4th hour

  • Pain Score

    Postoperative 8th hour

  • Pain Score

    Postoperative 12th hour

  • Pain Score

    Postoperative 24th hour

Study Arms (2)

Paracetamol

SHAM COMPARATOR

Patients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase.

Drug: Intravenous Infusion

Transversus Abdominis Plane Block

ACTIVE COMPARATOR

With USG, the lateral part of the latissumus dorsi muscle attaches to the external lip of the iliac crest, just behind the middle axillary line and the end is directed slightly cranially, first through the external oblique muscle and fascia, then the internal oblique muscle and fascia, and after hydrodissection with saline for about 15-20 ml of local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally

Procedure: Local anesthesia

Interventions

Intravenous InfusionDRUG

analgesic

Also known as: Paracetamol
Paracetamol
Local anesthesiaPROCEDURE

Local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally to transverses abdominis muscle

Transversus Abdominis Plane Block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute stony cholecystitis
  • Acute acalculous cholecystitis
  • years old

You may not qualify if:

  • Open cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yahya Gumusoglu A, Ferahman S, Gunes ME, Surek A, Yilmaz S, Aydin H, Gezmis AC, Aliyeva Z, Donmez T. High-Volume, Low-Concentration Intraperitoneal Bupivacaine Study in Emergency Laparoscopic Cholecystectomy: A Double-Blinded, Prospective Randomized Clinical Trial. Surg Innov. 2020 Oct;27(5):445-454. doi: 10.1177/1553350620914198. Epub 2020 Apr 3.

    PMID: 32242764BACKGROUND

  • Peng K, Ji FH, Liu HY, Wu SR. Ultrasound-Guided Transversus Abdominis Plane Block for Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Med Princ Pract. 2016;25(3):237-46. doi: 10.1159/000444688. Epub 2016 Feb 16.

    PMID: 26885872RESULT

MeSH Terms

Conditions

Bites and StingsCholecystitis, AcutePain, Postoperative

Interventions

Infusions, IntravenousAcetaminophenAnesthesia, Local

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesCholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, ParenteralAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Turgut Donmez, Ass. Prof.

    Bakirkoy Sadi Konuk

    STUDY DIRECTOR

Central Study Contacts

Husnu Aydin, MD

CONTACT

00905322471152drhusnuaydin@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Dr.

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 23, 2021

Study Start

March 15, 2021

Primary Completion

September 15, 2021

Study Completion

October 15, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share