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

NCT05729308 | Unknown

• 1 other identifier: md 335/2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• postoperative analgesia

  using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  immediately postoperative

• postoperative analgesia

  using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  2 hours postoperative

• postoperative analgesia

  using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  6 hours postoperative

• postoperative analgesia

  using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  12 hours postoperative

• postoperative analgesia

  using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  24 hours postoperative

Secondary Outcomes (7)

• intraoperative mean arterial blood pressure

  every 10 minutes intraoperative till end of surgery

• intraoperative heart rate

  every 10 minutes intraoperative till end of surgery

• postoperative first rescue analgesia time

  during the 24 hours postoperative

• Surgical field bleeding.

  from the start till the end of the operation

• Number of participant with postoperative nausea

  during the 24 hours postoperative

Study Arms (3)

Group (CE): Patients receiving caudal epidural block

ACTIVE COMPARATOR

Procedure: caudal epidural block

Group (ESP): Patients receiving bilateral erector spinae plane block.

ACTIVE COMPARATOR

Procedure: bilateral erector spinae plane block

Group (C): Control group, patients receiving general anesthesia with intravenous analgesia.

ACTIVE COMPARATOR

Procedure: general anesthesia with intravenous analgesia.

Interventions

caudal epidural block PROCEDURE

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

Group (CE): Patients receiving caudal epidural block

bilateral erector spinae plane block PROCEDURE

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

Group (ESP): Patients receiving bilateral erector spinae plane block.

general anesthesia with intravenous analgesia. PROCEDURE

* 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.

Group (C): Control group, patients receiving general anesthesia with intravenous analgesia.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for lumbosacral spine surgery level from L4 to S1.
• American Society of Anesthesiologists classification (ASA) class I or II.

You may not qualify if:

• Refusal of procedure or participation in the study.
• American Society of Anesthesiologists classification (ASA) class III or IV.
• Coagulation disorders (platelets count \< 100,000; International normalized ratio \>1.4; Patient control time\< 60%) and coagulopathies.
• Skin lesion or infection at the injection site.
• Known allergy to any of the medications used.
• Chronic opioid users.
• Patients with pre-operative opioid consumption

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)