Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies

Study Overview
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Brief Summary
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The aim of the trial is to study the efficacy of bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic cholecystectomy

Detailed Description
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Laparoscopic cholecystectomy is one of the most common performed procedures of general surgery. Although it is performed with minimally invasive techniques, postoperative pain can be moderate to severe, requiring administration of large doses of opioids perioperatively in combination with other categories of analgesics in order to be relieved. Modern anesthesiology practices tend to limit the opioids administered to patients due to a variety of complications observed, specifically in certain populations (obese, elderly) and also due to the opioid crisis appearance in United States and in many European countries. As such, multimodal analgesia and opioid limitation is the cornerstone of modern perioperative pain management. Peripheral nerve blocks and especially trunk blocks can play a significant role when confronting perioperative pain. Erector spinae Plane Block (ESPB) is a novel trunk block first described in order to relieve thoracic neuropathic pain. Since then, it was performed by anesthesiologists for chronic pain, acute post traumatic pain and in a wide variety of surgical procedures for postoperative analgesia. There are no trials that study the efficacy of adding dexmedetomidine as an adjuvant to the local anesthetic in order to ameliorate the quality and extend the duration of the Erector Spinae Plane Block. This trial is a randomized, controlled, double - blind, prospective trial, aiming at assessing the efficacy of bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic cholecystectomy. In this trial, 60 patients (men and women), aged 18 to 70 years old that will undergo laparoscopic cholecystectomy which will be performed by the same experienced, surgical team, will be recruited. Patients will be randomized into three groups, Group D (Ropivacaine plus dexmedetomidine group), Group R (Plain Ropivacaine group) and Group C (Control group). The solutions that will be administered during the performance of ESPB, will be prepared by an independent anesthesiologist. The ultrasound image during the performance of ESPB, as well as the complications that may arise after the performance of the block, will be recorded. The age, sex, American Society of Anesthesiologists (ASA) classification, height and weight of the participants, will be recorded. After the induction of general anesthesia [propofol (2-3 mg/kg), fentanyl (2-3 γ/kg), rocuronium (0,6 mg/kg)], general anesthesia will be maintained with desflurane titration. In all patients, remifentanil infusion will be titrated in order to achieve intraoperative analgesia (Systolic Arterial Blood Pressure within the 20% of Baseline Systolic Blood Pressure). In all patients Paracetamol 1000 mg and Tramadol 100 mg will be administered, 30 minutes before the end of surgery. During surgery, vital signs, remifentanil infusion or other drugs that will be administered, will be recorded. At the end of surgery, Train of Four stimulation will be performed and in the presence of remaining neuromuscular blockade, sugammadex will be administered in the proper doses. In all patients, post - operative analgesia will be offered with a Patient controlled Analgesia (PCA) pump, containing morphine. Lock - out period will be 10 minutes and the morphine dose will be 20 mcg/kg, without continuous infusion. The duration of stay of the patient in Post Anesthesia Care Unit (PACU), will be recorded as well as the Aldrete Score and the vital signs the moment the patient leaves the PACU. Postoperative pain will be recorded at arrival and discharge of the patient from the PACU, as well as 3, 6, 12 and 24 hours after the end of surgery, according to NRS pain scale. All patients will receive Paracetamol 1000 mg x 3 (iv) at the surgical ward. Post - operative nausea and vomiting, morphine consumption and the vital signs of the patients will be recorded 3, 6, 12and 24 hours after surgery. The mobilization time, hospitalization time, as well as the satisfaction score of the patient in a scale from 1 to 6, 24 hours after the end of surgery will be recorded.

Official Title
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The Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies. A Randomized, Controlled, Double Blind, Prospective, Trial

Conditions
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Pain, Postoperative, Pain Syndrome, Pain, Acute, Anesthesia, Cholecystectomy, Erector Spinae Plane Block

Intervention / Treatment
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* Procedure: Group Dexmedetomidine
* Procedure: Group Ropivacaine
* Procedure: Group Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I, II Laparoscopic cholecystectomy Elective surgery Exclusion Criteria: Patient refusal Coagulation disorders Known allergies to local anesthetics Other contraindications to regional anesthesia Infection or anatomic anomalies on injection site Uncontrolled hypertension Severe liver or kidney disease Pregnancy Known depression or psychiatric disorders, dementia Drug or alcohol abuse Inadequate command of Greek language

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Dexmedetomidine<br>Ropivacaine plus dexmedetomidine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) plus dexmedetomidine 1 mcg/kg | Procedure: Group Dexmedetomidine<br>* Ropivacaine plus dexmedetomidine group<br>|
| Active Comparator: Group Ropivacaine<br>Plain ropivacaine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) | Procedure: Group Ropivacaine<br>* Plain ropivacaine group<br>|
| Placebo Comparator: Group Control<br>Control group - Preoperative bilateral erector spinae plane block with N/S 0,9% (40 ml) | Procedure: Group Control<br>* Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score 3 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 3 hours after surgery | 
| pain score 6 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 6 hours after surgery | 
| pain score 12 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 12 hours after surgery | 
| pain score 24 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 24 hours after surgery | 
| pain score on arrival to Post-Anesthesia Care Unit (PACU) | pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | immediately postoperatively | 
| pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU | immediately postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | morphine consumption through patient-controlled analgesia device for 24 hours postoperatively | 24 hours postoperatively | 
| satisfaction from postoperative analgesia | satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction | 24 hours postoperatively | 
| mobilization time | time at which the patient mobilizes after surgery | 24 hours postoperatively | 
| hospitalization time | duration of hospital stay after surgery in days | 72 hours postoperatively | 
| intraoperative dose of remifentanil infusion (μg kg-1) | dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure within the 20% of baseline value | intraoperatively | 
| Erector Spinae Plane Block-related complications | block-related complications at the site of the local anesthetic injection | 48 hours postoperatively | 
| Post Anesthesia Care Unit (PACU) duration of stay | duration of patient stay at PACU | immediately postoperatively |