Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic Subcostal transverse abdominis plane block (STAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and STAP in laparoscopic cholecystectomy.

Official Title
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Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy, Randomised Controlled Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: Standard Pain Followup and Monitorization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II-III Undergoing elective laparoscopic cholecystectomy Exclusion Criteria: obesity ASA IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Controlled randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector Spinae Block<br>Ultrasound-guided bilateral Erector spinae plane block performed at end of the surgery with 40 ml of a bupivacaine/prilocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. | Other: Standard Pain Followup and Monitorization<br>* Numeric Rating Scale (NRS) pain score will be recorded from recovery room followed by 2.-4.-6.-12.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 4 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.<br>|
| Active Comparator: Subcostal Abdominis Plane Block<br>Ultrasound-guided bilateral STAP block performed at end of the surgery with 40 ml of a bupivacaine/prilocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. | Other: Standard Pain Followup and Monitorization<br>* Numeric Rating Scale (NRS) pain score will be recorded from recovery room followed by 2.-4.-6.-12.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 4 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using | at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours | 
| block related complication | local anesthetic systemic toxicity during and after block procedure , pneumothorax and vascular puncture during block procedure | in this block performing time, till patients anesthetized right after block procedure, at PACU, 2nd, 4th, 6th, 12th and 24th hours | 
| opioid complication | sedation, itching, nausea and vomiting | at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours |