Ultrasound Guided Bilateral Erector Spinae Block Versus Caudal in Lumbar Spine Surgeries

NCT05351203 | Completed

• 1 other identifier: MS-620-2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) as a new technique of trunk fascia block was proposed in 2016Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics. The aim of this work is to evaluate the pre-emptive analgesic effect of Ultrasound guided bilateral erector spinae block Vs Caudal epidural analgesia in Lumbar spine surgeries during peri-operative period. Objectives:

• To assess the duration of analgesia in both groups and time to rescue analgesia .
• To assess Visual analogue scale (VAS) score in both groups.
• To assess complications of both groups

Conditions

Acute Postoperative Pain

Keywords

caudal; Erector spinae block; lumbar surgery

Outcome Measures

Primary Outcomes (1)

• time to first analgesia request

  postoperative first rescue analgesia time

  12 hours

Secondary Outcomes (5)

• cumulative 24 hours opioid consumption

  24 hours

• presence of any complications

  24 hours

• Mean arterial blood pressure

  evey 10 minutes intraoperative till end of surgery (up to 2 hours)

• Heart rate

  every 10 minutes intraoperative till end of surgery(up to 2 hours)

• VAS score

  at 15 & 30 mins, then at 2, 6, 12, 24 hours post-operatively

Study Arms (2)

caudal epidural group

ACTIVE COMPARATOR

the patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock by betadine three times and will be covered by sterile drapes exposing the sacral area. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound linear transducer probe that is covered in sterile plastic bag . Short axis (transverse) 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) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.

Procedure: caudal block

Erector spinae group

EXPERIMENTAL

● The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound) will be placed sagittal 3 cm lateral to L3 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, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.

Procedure: Erector spinae block

Interventions

caudal block PROCEDURE

. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound,. Short axis (transverse) 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) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.

Also known as: caudal epidural block

caudal epidural group

Erector spinae block PROCEDURE

● The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound) will be placed sagittal 3 cm lateral to L3 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, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.

Also known as: ESP block

Erector spinae group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing Lumbar spine surgery (L1-L5).
• American society of anesthesiologists classification (ASA) I and II.

You may not qualify if:

• Patient's refusal.
• Bleeding disorders (platelets count \< 150,000; International normalized ratio \>1.5; PC\< 60%) and coagulopathies.
• Skin lesion, wounds or infection at the injection site.
• Known allergy to local anesthetic drugs.
• Chronic opioid or NSAIDS users.
• Patients with pre-operative opioid consumption

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospitals

Giza, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• mohamed F mohamed, ass prof.

  Anesthesia department , Cairo university

  STUDY DIRECTOR

• Gomaa Z Hussein, professor

  Anesthesia department , Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: May 8, 2022
• Primary Completion: September 15, 2022
• Study Completion: May 22, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)