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Transversus Abdominis Plane (TAP) BlockPhase 3NCT04767542

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

A Phase 3 study testing Intravenous Infusion and Local anesthesia in people with Transversus Abdominis Plane (TAP) Block, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Transversus Abdominis Plane (TAP) Block
What is being tested?
Intravenous Infusion and Local anesthesia
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
No sites listed yet
Study dates
15 Mar 2021to 15 Oct 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Open cholecystectomy

Trial locations and contacts

No sites are listed yet.

Husnu Aydin, MD contact

00905322471152

drhusnuaydin@gmail.com

About this study

Official title: Bakirkoy Dr. Sadi Konuk Training and Research Hospital

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.

Read the 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.

Being tested
Intravenous Infusion, Local anesthesia
Keywords
acute cholecystitis, postoperative pain, transversus abdominis plane block
Medical subject headings
Bites and Stings, Cholecystitis, Acute, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous InfusionDrug

    Also called Paracetamol

    analgesic

  • Local anesthesiaProcedure or surgery

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

Study groups in NCT04767542
Study groupRoleWhat they receive
ParacetamolSham comparatorPatients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase.
Receives: Drug: Intravenous Infusion
Transversus Abdominis Plane BlockActive comparatorWith 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
Receives: Procedure: Local anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Score

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

    Measured: Preoperative 1th hour

Secondary outcomes (5)

  1. Pain Score

    Postoperative Verbal Rating Score will be done

    Measured: Postoperative 1st hour

  2. Pain Score

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

    Measured: Postoperative 4th hour

  3. Pain Score

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

    Measured: Postoperative 8th hour

  4. Pain Score

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

    Measured: Postoperative 12th hour

  5. Pain Score

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

    Measured: Postoperative 24th hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start15 Mar 2021 (estimated)
  3. Primary completion15 Sep 2021 (estimated)
  4. Study completion15 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04767542
Sponsor's protocol ID
Bakirkoy Sadi Konuk
Status last verified
Mar 2021
First submitted
5 Feb 2021
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32242764

  • 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.

    PubMed 26885872

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous Infusion and Local anesthesia in people with Transversus Abdominis Plane (TAP) Block, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Husnu Aydin, MD (00905322471152, drhusnuaydin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score (time frame: Preoperative 1th hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767542, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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