search
Back to results

Postoperative Pain Difference for 'IV Paracetamol' and TAP Block' in Acute Cholecystitis

Primary Purpose

Transversus Abdominis Plane (TAP) Block

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intravenous Infusion
Local anesthesia
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transversus Abdominis Plane (TAP) Block focused on measuring acute cholecystitis, postoperative pain, transversus abdominis plane block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute stony cholecystitis
  • Acute acalculous cholecystitis
  • 18-70 years old

Exclusion Criteria:

  • Open cholecystectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Paracetamol

    Transversus Abdominis Plane Block

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 5, 2021
    Last Updated
    March 2, 2021
    Sponsor
    Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04767542
    Brief Title
    Postoperative Pain Difference for 'IV Paracetamol' and TAP Block' in Acute Cholecystitis
    Official Title
    Bakirkoy Dr. Sadi Konuk Training and Research Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2021 (Anticipated)
    Primary Completion Date
    September 15, 2021 (Anticipated)
    Study Completion Date
    October 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Patients to be included in the study will be selected from the group between the ages of 18 and 70 who apply to general surgery and emergency outpatient clinics, depending on patient approval. All patients will be informed about the surgery and procedures to be performed. Patients who agree to participate in the study will be included in the study. The study will be carried out by 2 surgeons with 5 years of laparoscopic cholecystectomy (LC) experience. Adult patients presenting with acute cholecystitis who underwent emergency LC by one of the two surgeons will be included in the study. These two surgeons will be responsible for participant registration. Patients with fever greater than 3.37.2 ℃, including 1) a diagnosis of acute cholecystitis confirmed by hepatobiliary ultrasound, 2) a high leukocyte count (> 7 × 109 / L), will be included in the study. Patients undergoing elective laparoscopic cholecystectomy (E-LC) and patients who are converted to an open procedure will be excluded from the study. Patients will be divided into two groups. In Group A, patients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase. In Group B, the lateral part of the latissumus dorsi muscle attaches to the external lip of the iliac crest, behind the middle axillary line and the end is directed towards the cranial, firstly the external oblique muscle and fascia, then the internal oblique muscle and fascia, and after hydrodissection with saline physiological. 15-20 ml of local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally. Standard laparoscopic cholecystectomy will be applied in two groups. Nasogastric tube will be inserted after intubation in both groups and will be removed at the end of the operation. Age, height, weight, ASA score, body mass index, duration of surgery, complications, comorbidities, fever, leukocyte, CRP levels, ALT, AST, GGT, total bilirubin, direct bilirubin values will be recorded. Pulse, heart rate, systolic and diastolic pressures, Oxygen saturation (with a palimeter) will be recorded during surgery in both groups. VAS and VRS pain scoring will be done after surgery. VAS (Visuale analogue score) 0-10 cm and VRS (no pain in cough (score = 0); pain in cough, not in deep breathing (score = 1); pain in deep breathing, but not at rest (score = 2); at rest pain will be evaluated as mild (score = 3); pain at rest, severe (score = 4)). Evaluations will be made statistically between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transversus Abdominis Plane (TAP) Block
    Keywords
    acute cholecystitis, postoperative pain, transversus abdominis plane block

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Paracetamol
    Arm Type
    Sham Comparator
    Arm Description
    Patients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase.
    Arm Title
    Transversus Abdominis Plane Block
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Infusion
    Other Intervention Name(s)
    Paracetamol
    Intervention Description
    analgesic
    Intervention Type
    Procedure
    Intervention Name(s)
    Local anesthesia
    Intervention Description
    Local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally to transverses abdominis muscle
    Primary Outcome Measure Information:
    Title
    Pain Score
    Description
    Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
    Time Frame
    Preoperative 1th hour
    Secondary Outcome Measure Information:
    Title
    Pain Score
    Description
    Postoperative Verbal Rating Score will be done
    Time Frame
    Postoperative 1st hour
    Title
    Pain Score
    Description
    Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
    Time Frame
    Postoperative 4th hour
    Title
    Pain Score
    Description
    Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
    Time Frame
    Postoperative 8th hour
    Title
    Pain Score
    Description
    Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
    Time Frame
    Postoperative 12th hour
    Title
    Pain Score
    Description
    Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
    Time Frame
    Postoperative 24th hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute stony cholecystitis Acute acalculous cholecystitis 18-70 years old Exclusion Criteria: Open cholecystectomy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Husnu Aydin, MD
    Phone
    00905322471152
    Email
    drhusnuaydin@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Turgut Donmez, Ass. Prof.
    Organizational Affiliation
    Bakirkoy Sadi Konuk
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32242764
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26885872
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Postoperative Pain Difference for 'IV Paracetamol' and TAP Block' in Acute Cholecystitis

    We'll reach out to this number within 24 hrs