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

March 2, 2021 updated by: Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Open cholecystectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Paracetamol
Patients with emergency LC will be administered intravenously 1 gr vial of paracetemol in 30 minutes during the awakening phase.
Drug: Intravenous Infusion
analgesic
Other Names:
  • Paracetamol
Active Comparator: Transversus Abdominis Plane Block
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
Local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally to transverses abdominis muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Preoperative 1th hour
Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
Preoperative 1th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Postoperative 1st hour
Postoperative Verbal Rating Score will be done
Postoperative 1st hour
Pain Score
Time Frame: Postoperative 4th hour
Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
Postoperative 4th hour
Pain Score
Time Frame: Postoperative 8th hour
Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
Postoperative 8th hour
Pain Score
Time Frame: Postoperative 12th hour
Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
Postoperative 12th hour
Pain Score
Time Frame: Postoperative 24th hour
Postoperative Verbal Rating Score and Visuale analogue scoring will be done.
Postoperative 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Director: Turgut Donmez, Ass. Prof., Bakirkoy Sadi Konuk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bakirkoy Sadi Konuk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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