Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Lumbosacral Spine Surgeries.

NCT05729308 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-02-15

No results posted yet for this study

Summary

It is widely believed that major lumbosacral spine surgeries are associated with severe postoperative pain that may delay the functional recovery of the patient. Caudal epidural injection (CE) has an important role in providing effective pain relief post lumbosacral spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) is a relatively new technique of trunk fascial block which was introduced in 2016. Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.The overall benefit of intravenous (IV) analgesia versus pre-emptive analgesia by caudal epidural or erector spinae block is still controversial.

The aim of this study is to compare the pre-emptive analgesic effect of bilateral erector spinae plane block versus Caudal epidural analgesia versus the conventional intravenous analgesia in adult patients undergoing lumbosacral spine surgeries under general anesthesia.

Conditions

  • Postoperative Pain, Acute

Interventions

PROCEDURE

caudal epidural block

The patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound guidance using SonoSite M Turbo(USA).The scanning probe is the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 megahertz linear array)that is covered in sterile plastic bag.Short axis (transverse view) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal view) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.25% bupivacaine will expand the epidural space

PROCEDURE

bilateral erector spinae plane block

The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of T12. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T12 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 15 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side

PROCEDURE

general anesthesia with intravenous analgesia.

* Multimodal therapy with acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs) will be used. * Vital data will be monitored as mentioned Intraoperatively, if the pulse rate and/or mean blood pressure increased above 20% of the baseline, IV fentanyl will be administered as an incremental dose of 50 µg. * The patients will be monitored for heart rate and blood pressure at regular 10-minute intervals. If blood pressure decreased more than 20% from baseline, then the patient will receive 500 mL saline infusion; if no response is seen, then 5 mg ephedrine will be administered. If heart rate decreased to 45 beats per minute, an IV injection of 0.1 mg /kg atropine will be administered.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-01-31
Completion
2024-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05729308 on ClinicalTrials.gov