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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Conditions
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Transversus Abdominis Plane (TAP) Block

Intervention / Treatment
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* Drug: Intravenous Infusion
* Procedure: Local anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute stony cholecystitis Acute acalculous cholecystitis 18-70 years old Exclusion Criteria: Open cholecystectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute cholecystitis, postoperative pain, transversus abdominis plane block