Erector Spinae Plane Block Versus Subcostal Anterior Quadratus Lumborum Block in Laparoscopic Cholecystectomy

NCT05158270 | Completed

• 1 other identifier: ZU-IRB #9090
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy; Quadratus Lumborum Block; Erector Spinae Plane Block

Keywords

Laparoscopic cholecystectomy; Quadratus lumborum block; Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• 24 hours Postoperative Total Opioid Consumption.

  24 hours Postoperative Total Opioid Consumption.

  First 24 hours Postoperative

Secondary Outcomes (5)

• Time of Performing the Block.

  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.

  First 24 hours Postoperative

• Postoperative NRS Scores

  First 24 hours Postoperative

• Postoperative Complications

  First 24 hours Postoperative

• Time to First Ambulation.

  First 24 hours Postoperative

Study Arms (3)

Ultrasound Guided Erector Spinae Plane Block

ACTIVE COMPARATOR

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. 30 mL of 0.25% bupivacaine will be injected. Procedure will be performed bilaterally.

Procedure: Ultrasound Guided Erector spinae plane block

Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block

ACTIVE COMPARATOR

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.

Procedure: Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block

Intravenous Multimodal Analgesia

OTHER

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.

Other: Intravenous Multimodal Analgesia

Interventions

Ultrasound Guided Erector spinae plane block PROCEDURE

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 Erector Spinae Plane Block

Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block PROCEDURE

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.

Also known as: Ultrasound Guided Quadratus Lumborum Block

Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block

Intravenous Multimodal Analgesia OTHER

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.

Intravenous Multimodal Analgesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 60 years, of both sexes.
• ASA class II - III.
• Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
• Body mass index (BMI) ≥ 30 kg/m².

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospitals

Zagazig, Sharqia Province, 44111, Egypt

Location

Related Publications (14)

• 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.

  PMID: 22031616 BACKGROUND

• 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.

  PMID: 23099039 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 28188621 BACKGROUND

• 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.

  PMID: 24356162 BACKGROUND

• 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.

  PMID: 23223115 BACKGROUND

• 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.

  PMID: 9952166 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 8519712 BACKGROUND

• 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.

  PMID: 18337271 BACKGROUND

• 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.

  PMID: 19500754 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Ashraf A Torki, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  PRINCIPAL INVESTIGATOR

• Mona A Shahin, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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 ESPB. Group II (AQL Group): will receive US-guided AQLB. Group III (Control Group): will receive IV multimodal analgesia only. Both patients and data collector responsible for assessing outcomes will be blinded to group assignment (double-blinded clinical trial).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Zagazig University

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: November 15, 2021
• Primary Completion: August 25, 2024
• Study Completion: September 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)