Erector Spinae Plane Block As Alternative Analgesic Modality in Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158270
• Other study ID #: 9090
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: May 2024
• Source: Zagazig University
• Contact: Ashraf A Torki, MD
• Phone: 01009812398
• Email: dr.ashraf.anesthesia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Subcostal approach to Anterior quadratus lumborum block (SAQLB), 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 SAQLB following laparoscopic cholecystectomy.

Description:

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 subcostal anterior quadratus lumborum block (SAQLB).

Group III (Control Group): will receive intravenous (IV) multimodal analgesia only.

Clinician performing the blocks and patients will not be blinded, but investigators evaluating the outcomes will be blinded to the randomization to keep the data analysis unbiased.

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 him. Standard fasting guidelines will be also explained to the patients, i.e., no solid foods for 6 - 8 hrs (depending on fat content of the food) and no clear liquids for 2 hrs. Also, for aspiration prophylaxis, all patients will be instructed to take Erythromycin tablet 250 mg with Ranitidine tablet 150 mg, with 10 ml of water 2 hrs before procedure.

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:

1. 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.

2. Immediately after Induction: Dexamethasone 4 mg IV will be given to all patients for prevention of postoperative nausea and vomiting (PONV).

3. 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 Nalbuphine (0.1 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 SAQLB. 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, Nalpuphine, as 3 mg IV bolus at each dose, will be given when Numerical Rating Scale (NRS) ≥ 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses.

Measured Parameters:

1. Time of Performing the Block.

2. 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.

3. Postoperative Pain;

A. Patients will be instructed how to represent their level of pain using NRS 0 to 10, 0 indicated no pain, and 10 indicated the most intense pain. Taking the procedures of laparoscopic cholecystectomy (LC) into account, pain assessment was performed in four domains: pain when coughing, pain at rest, incision pain and visceral pain. Specific questions were used respectively:

"What is NRS pain scores when you cough?" "What is your NRS pain scores when you lay down in a quiet situation?" "What is your NRS pain scores on the incision site?" "What is your NRS pain scores about dull pain inside the abdomen?" NRS 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.

B. Shoulder pain (SP) will be assessed using a 3 point scale (0 = none, 1 = mild and 2 = severe) at the same time points.

4. Time of Postoperative First Opioid Analgesic Request.

5. Total Opioid Consumption in the First 24 hrs Postoperative.

6. Time To Recovery Of Intestinal Function; defined as time from recovery to first flatus.

7. Time To First Ambulation; defined as time from T0 until the subject was able to stand up and walk without support.

8. 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:

1. Pain:

2. 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.

3. Technical Complications; Include visceral injury, hematoma formation, lower extremity weakness and local anesthetic systemic toxicity (LAST).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 60 years, of both sexes.

2. ASA class I - III.

3. Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.

4. Body mass index (BMI) = 30 kg/m².

Exclusion Criteria:

1. Age < 18 or > 60 years.

2. ASA IV patients.

3. Body mass index (BMI) = 40 kg/m².

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. chronic pain characterized by opioid use for > 30 consecutive days within the 3 preoperative months at a dose equivalent to at least 15 mg of morphine.

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Laparoscopic Cholecystectomy
• Quadratus Lumborum Block

Intervention

Procedure:
• Ultrasound Guided Erector spinae plane block
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.
• Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block
Patients will be positioned lateral decubitus. A curvilinear 2-5 MHz ultrasound transducer (SonoSite S-Nerve, Bothell, WA) will be positioned posteriorly below the 12th rib in a parasagittal oblique plane at L1-2 level. The QL muscle was visualized and its point of insertion on the 12th rib identified. An 18-gauge Tuohy needle was advanced in the caudal-to-cranial direction between QL muscle and the psoas major muscle until a click could often be felt as the needle tip penetrated the anterior investing fascia of the QL muscle. After a negative aspiration, 30 mL of 0.25% bupivacaine was injected through the needle to help confirm the final needle tip position, anterior to the QL muscle at close proximity to the 12th rib.

Other:
• Intravenous 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, Nalpuphine, as 3 mg IV bolus at each dose, will be given when Numerical Rating Scale (NRS) = 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses.

Locations

Country	Name	City	State
Egypt	Zagazig university hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

Børglum J, Jensen K, Moriggl B, Lönnqvist P, Christensen AF, Sauter A and Bendtsen TF: Ultrasound-guided transmuscular quadratus lumborum blockade. Br J Anesth 2013;110 (3):297-300.

Caljouw MA, van Beuzekom M, Boer F. Patient's satisfaction with perioperative care: development, validation, and application of a questionnaire. Br J Anaesth. 2008 May;100(5):637-44. doi: 10.1093/bja/aen034. Epub 2008 Mar 12. — View Citation

Capogna G, Celleno D, Laudano D, Giunta F. Alkalinization of local anesthetics. Which block, which local anesthetic? Reg Anesth. 1995 Sep-Oct;20(5):369-77. — View Citation

Carassiti M, Cappiello D, Galli B. One shot six centres: a new strategy in ultrasound guided paravertebral block. J Anesth Clin Res. 2015;6: 580 - 583. doi:10.4172/2155-6148.1000580

Chen CK and Phui VE. The efficacy of ultrasound-guided oblique subcostal transversus abdominis plane block in patients undergoing open cholecystectomy. Southern African Journal of Anaesthesia and Analgesia. 2011;17(4):308-10.

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. — View Citation

De Oliveira GS Jr, Castro-Alves LJ, Ahmad S, Kendall MC, McCarthy RJ. Dexamethasone to prevent postoperative nausea and vomiting: an updated meta-analysis of randomized controlled trials. Anesth Analg. 2013 Jan;116(1):58-74. doi: 10.1213/ANE.0b013e31826f0a0a. Epub 2012 Dec 7. — View Citation

Fitzgibbon DR and McQuay H. Respiratory Depression: Incidence, Diagnosis, and Treatment. In: Sinatra RS, de Leon-Cassasola OA, Viscusi ER, Ginsberg B, editors. Acute Pain Management. Cambridge: Cambridge University Press; 2009. p. 416-30.

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494. — View Citation

Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28. — View Citation

Melnyk M, Casey RG, Black P, Koupparis AJ. Enhanced recovery after surgery (ERAS) protocols: Time to change practice? Can Urol Assoc J. 2011 Oct;5(5):342-8. doi: 10.5489/cuaj.11002. — View Citation

Pasero C. Assessment of sedation during opioid administration for pain management. J Perianesth Nurs. 2009 Jun;24(3):186-90. doi: 10.1016/j.jopan.2009.03.005. No abstract available. — View Citation

Peng PW, Sandler AN. A review of the use of fentanyl analgesia in the management of acute pain in adults. Anesthesiology. 1999 Feb;90(2):576-99. doi: 10.1097/00000542-199902000-00034. No abstract available. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours Postoperative Total Opioid Consumption.	24 hours Postoperative Total Opioid Consumption.	First 24 hours Postoperative
Secondary	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.)
Secondary	Time of Postoperative First Opioid Analgesic Request.	Time of Postoperative First Opioid Analgesic Request.	First 24 hours Postoperative
Secondary	Postoperative NRS Scores	NRS 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
Secondary	Postoperative Complications	including sedation, respiratory depression, PONV, visceral injury, hematoma formation, lower extremity weakness, and LAST.	First 24 hours Postoperative
Secondary	Time to First Ambulation.	time until the subject was able to stand up and walk without support.	First 24 hours Postoperative