Erector Spinae Plane Block As Alternative Analgesic Modality in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Adequate analgesic regimen is one of the most important key elements of Enhanced recovery after surgery (ERAS) protocols. The cornerstone of analgesia is multimodal analgesia combining local anesthetic (LA) techniques and trying to avoid parenteral opioids and their side effects. Anterior quadratus lumborum block (AQLB), compared to other variants of quadratus lumborum blocks (QLBs), was associated with wider and longer sensory blockade, and provided somatic as well as visceral analgesia of the abdomen. The newly emerging, relatively easy erector spinae plane block (ESPB) provided excellent analgesia across a variety of surgical procedures and reduced opioid consumption. This motivated us to do this study to assess and compare the analgesic efficacy of ESPB versus AQLB following laparoscopic cholecystectomy.

Detailed Description
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Site of the Study: Zagazig university surgical hospitals. Type of the Study: Prospective randomized double-blinded clinical trial. Sample Size: The sample size is calculated to be 60 (30 for each group), using open epi program with confidence level of 95% and power of test 80%, assuming that the mean ± standard deviation of 24 hrs postoperative total opioid consumption among group of patients undergoing ESBP technique versus control group is 130 ± 88 and 201 ± 78, respectively. Withdrawal Criteria: The patient has the right to withdraw from the study at any time without any negative consequences on medical or surgical treatment plan. Randomization: Computer-generated randomization numbers will be used to randomly assign patients into 3 groups using sealed opaque envelopes that will be randomly selected by each patient and contained a group number in which the patient was enrolled. Once enrolled in the study, patients will be randomly assigned into 3 groups; Group I (ESP Group): will receive US-guided erector spinae plane block (ESPB). Group II (AQL Group): will receive US-guided anterior quadratus lumborum block (AQLB). Group III (Control Group): will receive intravenous (IV) multimodal analgesia only. Both patients and data collector responsible for assessing outcomes will be blinded to group assignment (double-blinded clinical trial). Type of the Study: Prospective randomized double-blinded clinical trial. Steps of Performance: A. Intraoperative Management: Preoperative Assessment: All patients will be assessed by careful history taking, clinical examination and laboratory investigations. Laboratory work needed included; Complete blood count (CBC), biochemistry and coagulation profile. Other investigations (e.g., electrocardiography [ECG], echocardiography, and chest x-ray) will be done according to the patient's medical condition. Preoperative Preparation: The day before surgery, the purpose of this study, benefits from the block and possible complications that may occur will be explained clearly to the patient. After that, informed written consent will be obtained from her/him. Patients will be instructed how to represent their level of pain using the visual analogue scale (VAS) of 10-cm unmarked horizontal line. A piece of paper will be held in front of the patient showing a continuous line with no pain at one end and worst pain on the other end. The patient will be asked to mark a point on the line that corresponds best to his present level of pain intensity. On the paper side facing the recorder, this line will be translated to numbers that only he can see, then he will record the number that corresponds to the patient's point. 0 points = no pain and 10 points = the worst pain imaginable). Premedication: On arrival to the operating room, and after ensuring of working 18 gauge IV line, midazolam (2 mg) will be given IV for anxiolysis, then IV fluid drip will be started. B. Intraoperative Management: Intraoperative Monitoring: Monitoring will be applied and maintained throughout the procedure, including 5- lead electrocardiogram (ECG), non-invasive arterial blood pressure, pulse oximeter, and capnography. Hemodynamic parameters including heart rate (HR) and mean arterial blood pressure (MAP), will be recorded after receiving sedation (baseline data) and intraoperative immediately after induction, then every 5 minutes for 15 minutes, then every 15 minutes afterwards till the end of surgery. General Anesthesia: Induction and Intubation: Pre-oxygenation; will be done by asking the patient to take 8 vital capacity breaths of 100% O2 over one min. via a tightly fitting face-mask. Intravenous induction will be done using Fentanyl (1 µg/kg), Propofol (2 mg/kg) and Cis-atracurium (0.15 mg/kg). Mask ventilation will be done with 100% O2 for 3 min. until complete muscle paralysis. Endotracheal tube of suitable size will be used for tracheal intubation. Immediately after Induction: Dexamethasone 5 mg IV will be given to all patients for prevention of postoperative nausea and vomiting (PONV). Maintenance: Anesthesia will be maintained with oxygen and 1.5% isoflurane. Additional doses of cis-atracurium (0.04 mg/kg) will be given when needed, guided by nerve stimulator. Volume-controlled mechanical ventilation will be used to maintain end-tidal carbon dioxide of 35-40 mmHg. Ventilator settings will be tidal volume 8 ml/kg and respiratory rate 10-15/min. IV Fentanyl infusion (1 µg/kg/hr) will be maintained intraoperative and titrated up to 2 µg/kg/hr; according to patient's vital signs after exclusion of other causes of hemodynamic instability. Fentanyl infusion will be discontinued 20 min. before the end of surgery. 30 min. before the end of surgery, all patients will receive a combination of IV multimodal analgesia for postoperative pain control in the form of Acetaminophen (15 mg/kg), Ketorolac (0.5 mg/kg) and Morphine (0.2 mg/kg). Block Technique: At the end of the surgical procedure, while patients are still under general anesthesia, the patient's envelope which contains the number of group will be opened and it will be recorded in the data collection sheet as a number of group because the data collector will be blind to the intervention which will be done to the patient, only the anesthetist knows each number will be referring to which intervention. I) Group I (ESP Group): will receive US-guided ESPB. II) Group II (AQL Group): will receive US-guided AQLB. III) Group III (Control Group): will receive IV multimodal analgesia only. Block techniques will be performed under complete aseptic precautions. Time of Performing the Block: It will be recorded and defined as the time from placement of US probe on the patient's skin till the end of local anesthetic (LA) injection. It represents the time needed for adequate ultrasonic visualization, needle introduction and drug injection. The time for skin preparation, draping, and probe sheathing will not be included. Recovery from General Anesthesia: After completion of blockade, isoflurane will be discontinued, residual neuromuscular blockade will be antagonized using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg) administered IV, and the patient will be extubated. Block Assessment: After recovery from general anesthesia, sensory blockade will be confirmed on both sides at the level of T6 dermatomal level (at the level of the xiphoid process) by pin prick using Hollmen scale for sensory block, as follows; 1 = Normal sensation of pinprick, 2 = Pin prick felt as sharp pointed but weaker when compared with unblocked area, 3 = Pin prick felt as touch with blunt object, 4 = No perception of pin prick. Hollmen scores will be recorded at an interval of 5 min. till a complete sensory block will be achieved, i.e., Hollmen score = 4. Cases of failed block, who would have Hollmen sensory scale of 1 for 30 min. after LA injection, will be excluded from the study. C. Postoperative Management: Multimodal Analgesia: Postoperative pain in the post-anesthesia care unit (PACU) and on the ward will be treated with a combination of IV multimodal analgesia in the form of Acetaminophen (15 mg/kg 4/day) and Ketorolac (0.5 mg/kg 3/day) using a fixed scheme. In addition, Morphine, as 3 mg IV bolus at each dose, will be given when VAS equals or above 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses. Measured Parameters: Time of Performing the Block. Postoperative Hemodynamics; including; heart rate (HR), mean arterial blood pressure (MAP), respiratory rate (RR), and oxygen saturation (SpO2) will be recorded immediately postoperative, then every hour for the first 4 hrs, and then every 4 hrs till the end of the first 24 hrs postoperative. Postoperative Pain; will be assessed at both rest and movement (sitting from lying down position) using VAS which will be recorded by the data collector who will be blind to the intervention done to the patient. Pain assessment will be done 30 min. postoperative, then at 2, 4, 6, 8, 12, 18 and 24 hrs postoperative. Time of Postoperative First Opioid Analgesic Request. Total Opioid Consumption in the First 24 hrs Postoperative. Patient Satisfaction; will be also considered and recorded at the end of the first 24 hrs postoperative using a 5-point scale of completely dissatisfied to completely satisfied as follows; 1 = Completely dissatisfied, 2 = Dissatisfied, 3 = Neither satisfied, nor dissatisfied, 4 = Satisfied, 5 = Completely satisfied. Complications: Pain: It will be observed and recorded using VAS during rest and movement. Morphine, as 3 mg IV bolus at each dose, will be given when the VAS equals or above 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses. Undesirable Effects of Opioid Usage; A. Sedation: will be measured using Pasero opioid-induced sedation scale (POSS); S; Sleep, easy to arouse, 1; Awake and alert, 2; Slightly drowsy, easily aroused, 3; Frequently drowsy, arousable, drifts off to sleep during conversation, 4; Somnolent, minimal or no response to verbal and physical stimulation. B. Respiratory Depression: defined as decreased respiratory rate (RR) < 8-10 breaths/minute or decreased oxygen saturation (SpO2) < 90%. Naloxone will be administered in case of excessive sedation and/or respiratory depression. Times of excessive sedation or respiratory depression, and total requirements of naloxone reversal in the first 24 hrs postoperative will be recorded. C. Postoperative Nausea and Vomiting (PONV): will be measured using a categorical scoring system; 0 = none, 1 = mild, 2 = moderate, 3 = severe. Detection of nausea will be occurred when nausea score > 0 at any time point postoperatively. Ondansetron (4 mg) will be administered IV in case of nausea and/or vomiting. Frequency of PONV and total requirements of ondansetron in the first 24 hrs postoperative will be recorded. Technical Complications; Include visceral injury, hematoma formation, lower extremity weakness and local anesthetic systemic toxicity (LAST).

Official Title
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Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy, Is It a Promising Alternative Modality?

Conditions
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Laparoscopic Cholecystectomy, Quadratus Lumborum Block, Erector Spinae Plane Block

Intervention / Treatment
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* Procedure: Ultrasound Guided Erector spinae plane block
* Procedure: Ultrasound Guided Anterior Quadratus Lumborum Block
* Other: Intravenous Multimodal Analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 60 years, of both sexes. ASA class II - III. Scheduled to undergo laparoscopic cholecystectomy under general anesthesia. Body mass index (BMI) > 35 kg/m². Exclusion Criteria: 1. Age < 18 or > 60 years. 2. ASA IV patients. 4. Intraoperative conversion to open surgery. 5. Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy or infection at the site of injection. 6. Uncooperative patients or psychiatric disorders. 7. Spinal deformity or previous spine surgery. 8. Chronic use of analgesics or drug dependence.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound Guided Erector Spinae Plane Block<br>Patient will be placed in lateral decubitus position. By palpation of spinous processes starting from C7 downward, T7 spinous process will be located. Under complete aseptic precautions, linear probe of US machine will be placed in a transverse orientation at this level to identify tip of T7 transverse process (TP). By probe rotation into a longitudinal orientation, a parasagittal view will visualize skin and subcutaneous tissue, trapezius, and erector spinae (ES) muscle layers superficial to TPs. After local anesthetic (LA) infiltration, a 20 gauge spinal needle will be inserted in-plane and directed cranio-caudally until it contacts T7 TP. Target site for injection will be fascial plane deep to ES muscle. 1 mL saline will be injected to confirm correct needle-tip position by visualization of lifting of ES muscle off TP without distending the muscle and spreading cranio-caudally. 20 - 30 mL of 0.25% bupivacaine will be injected. Procedure will be performed bilaterally. | Procedure: Ultrasound Guided Erector spinae plane block<br>* Patient will be placed in lateral decubitus position. By palpation of spinous processes starting from C7 downward, T7 spinous process will be located. Under complete aseptic precautions, linear probe of US machine will be placed in a transverse orientation at this level to identify tip of T7 transverse process (TP). By probe rotation into a longitudinal orientation, a parasagittal view will visualize skin and subcutaneous tissue, trapezius, and erector spinae (ES) muscle layers superficial to TPs. After local anesthetic (LA) infiltration, a 20 gauge spinal needle will be inserted in-plane and directed cranio-caudally until it contacts T7 TP. Target site for injection will be fascial plane deep to ES muscle. 1 mL saline will be injected to confirm correct needle-tip position by visualization of lifting of ES muscle off TP without distending the muscle and spreading cranio-caudally. 20 - 30 mL of 0.25% bupivacaine will be injected. Procedure will be performed bilaterally.<br>|
| Active Comparator: Ultrasound Guided Anterior Quadratus Lumborum Block<br>Patient will be placed in lateral decubitus position. Under complete aseptic precautions, curved US probe will be placed in midaxillary line immediately above the iliac crest to identify anterior abdominal wall muscles. Probe will be then moved dorsally until visualization of transversus abdominis muscle becoming aponeurotic, then visualization of shamrock sign with psoas major muscle anteriorly, erector spinae muscle posteriorly and quadratus lumborum (QL) muscle adherent to the apex of L4 transverse process. After LA infiltration, a 20 gauge spinal needle will be inserted in-plane from posterior to anterior, and needle tip will be advanced through QL muscle, penetrating the ventral proper fascia of QL muscle. Target site for injection will be fascial plane between QL and psoas major muscles. 1 mL saline will be injected to confirm correct needle-tip position, followed by injection of 20 - 30 mL of 0.25% bupivacaine. Procedure will be performed bilaterally. | Procedure: Ultrasound Guided Anterior Quadratus Lumborum Block<br>* Patient will be placed in lateral decubitus position. Under complete aseptic precautions, curved US probe will be placed in midaxillary line immediately above the iliac crest to identify anterior abdominal wall muscles. Probe will be then moved dorsally until visualization of transversus abdominis muscle becoming aponeurotic, then visualization of shamrock sign with psoas major muscle anteriorly, erector spinae muscle posteriorly and quadratus lumborum (QL) muscle adherent to the apex of L4 transverse process. After LA infiltration, a 20 gauge spinal needle will be inserted in-plane from posterior to anterior, and needle tip will be advanced through QL muscle, penetrating the ventral proper fascia of QL muscle. Target site for injection will be fascial plane between QL and psoas major muscles. 1 mL saline will be injected to confirm correct needle-tip position, followed by injection of 20 - 30 mL of 0.25% bupivacaine. Procedure will be performed bilaterally.<br>* Other names: Ultrasound Guided Quadratus Lumborum Block;|
| Other: Intravenous Multimodal Analgesia<br>Postoperative pain in the post-anesthesia care unit (PACU) and on the ward will be treated with a combination of IV multimodal analgesia in the form of Acetaminophen (15 mg/kg 4/day) and Ketorolac (0.5 mg/kg 3/day) using a fixed scheme. In addition, Morphine, as 3 mg IV bolus at each dose, will be given when VAS equals or above 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses. | Other: Intravenous Multimodal Analgesia<br>* Postoperative pain in the post-anesthesia care unit (PACU) and on the ward will be treated with a combination of IV multimodal analgesia in the form of Acetaminophen (15 mg/kg 4/day) and Ketorolac (0.5 mg/kg 3/day) using a fixed scheme. In addition, Morphine, as 3 mg IV bolus at each dose, will be given when VAS equals or above 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours Postoperative Total Opioid Consumption. | 24 hours Postoperative Total Opioid Consumption. | First 24 hours Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Performing the Block. | Time from placement of US probe on the patient's skin till the end of local anesthetic injection. | Intraoperative (Time from placement of US probe on the patient's skin till the end of local anesthetic injection.) | 
| Time of Postoperative First Opioid Analgesic Request. | Time of Postoperative First Opioid Analgesic Request. | First 24 hours Postoperative | 
| Postoperative VAS Scores | VAS scores recorded 30 min. postoperative, then at 2, 4, 6, 8, 12, 18, and 24 hrs postoperative, during rest and movement. | First 24 hours Postoperative | 
| Postoperative Complications | including sedation, respiratory depression, PONV, visceral injury, hematoma formation, lower extremity weakness, and LAST. | First 24 hours Postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic cholecystectomy, Quadratus lumborum block, Erector spinae plane block