Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

Detailed Description
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In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

Official Title
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Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study

Conditions
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Postoperative Pain, Laparoscopic Cholecystectomy, Regional Anesthesia

Intervention / Treatment
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* Procedure: M-TAPA block
* Procedure: EXORA block
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: laparoscopic cholecystectomy surgery Patients with ASA (American Society of Anaesthetists) scores I and III will be included. Exclusion Criteria: Uncontrolled Arterial Hypertension Uncontrolled Diabetes Mellitus, Mental retardation , Antidepressant use Metabolic disorders, Bleeding diathesis Patients with a body mass index above 30.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, single-blind, observational study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M<br>ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block | Procedure: M-TAPA block<br>* ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed<br>Drug: Tramadol<br>* 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>|
| Active Comparator: Group E<br>Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block | Procedure: EXORA block<br>* Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed<br>Drug: Tramadol<br>* 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>|
| Active Comparator: Group P<br>Patient-controlled analgesia with tramadol | Drug: Tramadol<br>* 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tramadol consumption |  | Postoperative 24 hours | 
| side effect profile scores | 1. Nausea and vomiting scale (nausea-vomiting scale (NVS): No nausea is present, Mild nausea is present. Severe nausea is present. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered. | Postoperative 24 hours | 
| additional analgesic use | additional analgesic use | Postoperative 24 hours | 
| pinprick test | The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt. | Postoperative 24 hours | 
| Ramsay Sedation Scale | Ramsay Sedation Scale (RSS) : Anxiety, agitation are present; Cooperated,awake; Sedated , response to commands; Sleepy, immediately awoken by auditory stimulus or glabella tap; Sleepy, deep response to auditory stimulus or glabella tap and Sleepy, no response to auditory stimulus or glabella tap ) | Postoperative 24 hours |