Pain Management in Laparoscopic Cholecystectomies

Study Overview
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Brief Summary
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Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Detailed Description
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The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Official Title
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Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.

Conditions
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Nerve Block

Intervention / Treatment
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* Procedure: ESPB
* Procedure: PVB
* Procedure: CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged >18 years patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery Exclusion Criteria: Did not provide informed consent, Had any psychiatric or mental problem that prevented understanding of the informed consent form They were planned to undergo emergency cholecystectomy, Had any allergy or hypersensitivity to local anaesthetic, Had an infection in the needle entry area History of coagulopathy or the use of anticoagulants

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector Spinae Plane Block (ESPB)<br>The spinous processes of the vertebrae were marked up to T8 level. After providing antisepsis of the skin with 10% povidone iodine, the ultrasound probe was placed at T8 level parallel to the vertebral spine at T8. The transverse process (TP) and hyperechoic pleura were observed 2.5cm right lateral of the spinous process. Using the in-plane approach, the needle was placed in the caudal direction. After confirming displacement of the pleura with 0.5-1ml local anaesthetic (LA), 20ml 0.25% bupivacaine was administered for the block . | Procedure: ESPB<br>* Erector spinae plane block<br>|
| Active Comparator: Paravertebral Block (PVB)<br>After sterilisation of the skin with povidone iodine, the probe covered with a sterile sheath was placed 3cm lateral of the T8 spinous process. The trapezius, rhomboid major, and erector spinae muscles, and the TP of the vertebrae were visualised. The needle was placed craniocaudally within the fascial plane of the deep surface of the erector spina muscle above the bone shadow of the TP. The fluid dissemination was confirmed by raising the placement of the needle tip towards the erector spina muscle. 20ml 0.25% bupivacaine was applied to this region and the spread of local anaesthetic was observed | Procedure: PVB<br>* Paravertebral Block<br>|
| Active Comparator: Control<br>No block has been done | Procedure: CONTROL<br>* No block has been done<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total tramadol consumption | Consumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device. | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) at rest and when coughing | 11-point scale where 0=no pain and 10=worst pain | at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively | 
| Analgesic drug consumption other than tramadol | in mg | 24 hours postoperatively | 
| Heart Rate | beats /min | preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes) | 
| Mean arterial pressure (MAP) | mm-hg | preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes) | 
| Incidence of postoperative nausea & vomiting (PONV) | Number of patients developing PONV | 24 hours postoperatively | 
| Shoulder pain | Number of patients developing shoulder pain | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector Spinae Plane Block, Paravertebral Block, Laparoscopic Cholecystectomy