CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Ultrasound Guided Erector spinae plane block +2 moreprocedure
Likely dose
Not stated in record
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Search/NCT05158270
NCT05158270N/ACompleted

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

Zagazig University·interventional·Posted Dec 15, 2021·Updated Sep 19, 2024

In Brief

A clinical study evaluating Ultrasound Guided Erector spinae plane block, Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block, and 1 other intervention for Laparoscopic Cholecystectomy and 2 related conditions. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 15, 2021
Enrollment StartNov 15, 2021
Primary CompletionAug 25, 2024
Study CompletionSep 5, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.5 years ago

Interventions

Ultrasound Guided Erector spinae plane blockprocedure

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 Blockprocedure

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.

Intravenous Multimodal Analgesiaother

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.