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

Primary Purpose

Acute Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
caudal block
Erector spinae block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Postoperative Pain focused on measuring caudal, Erector spinae block, lumbar surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kasr Alainy Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

caudal epidural group

Erector spinae group

Arm Description

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.

● 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.

Outcomes

Primary Outcome Measures

time to first analgesia request
postoperative first rescue analgesia time

Secondary Outcome Measures

cumulative 24 hours opioid consumption
the total amount of opioid consumed by the patient in the first 24 hours postoperative
presence of any complications
presence of any complications such as urine retention,vomiting ,respiratory depression
Mean arterial blood pressure
intraoperative mean arterial blood pressure
Heart rate
intraoperative heart rate
VAS score
The visual analog score (VAS) is a validated,subjective measure for acute and chronic pain.scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain"

Full Information

First Posted
April 18, 2022
Last Updated
September 23, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05351203
Brief Title
Ultrasound Guided Bilateral Erector Spinae Block Versus Caudal in Lumbar Spine Surgeries
Official Title
Ultrasound Guide Bilateral Erector Spinae Block Versus Caudal Epidural Analgesia for Perioperative Analgesia in Lumbar Spine Surgeries:Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
May 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
This is a randomized controlled study designed to include 50 patients aged from 18 to 65 years old undergoing lumbar spine surgeries. fifty patients meeting the inclusion criteria will be randomly assigned into two equal groups: Group A(n=25): caudal epidural group. Group B(n=25): bilateral ultrasound guided Erector spinae block group. All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests . ● Operating Room preparation & Equipment: The ultrasound used will be SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 MHz linear array). Methods: General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. (14) Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight. (15) . The surgical intervention will be then allowed 20 minutes after finishing the block procedure. Volume controlled ventilation will be adjusted to maintain normocapnia. Anesthesia will be maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes. Patients will be placed in the prone position on a Relton Hall frame or padded bolsters. All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm every 24 hour, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis. Failed block (increase in Heart rate (HR) and mean arterial blood pressure (MABP)>20% from base line with skin incision) will be treated by 1 ug/kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl. After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered intravenous after return of patient's spontaneous breathing. Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring. At any time hypotension (defined as a decrease in mean arterial pressure (MAP) >25% from baseline value or systolic arterial pressure (SAP <100 mmHg)) will be treated with 5 mg IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved. Bradycardia (defined as a HR <40 beats per minute) will be treated with atropine 0.5 mg IV. In group (A): Caudal Epidural Analgesia For the caudal block, 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 transducer 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. In group (B): Bilateral Ultrasound guided Erector spinae group. 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 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. Rescue analgesia : Intra operative :0.5ug /kg of fentanyl as top-up doses at any time if blood pressure and heart rate increased by more than 20% from baseline reading . Post-operative : Nalbuphine (0.1 mg/kg) will be given if the pain score > 4/10 at the VAS assessment times or when the patient asks for supplementary analgesia due to an emerging pain in between the assessment points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain
Keywords
caudal, Erector spinae block, lumbar surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caudal epidural group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Erector spinae group
Arm Type
Experimental
Arm Description
● 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.
Intervention Type
Procedure
Intervention Name(s)
caudal block
Other Intervention Name(s)
caudal epidural block
Intervention Description
. 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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae block
Other Intervention Name(s)
ESP block
Intervention Description
● 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.
Primary Outcome Measure Information:
Title
time to first analgesia request
Description
postoperative first rescue analgesia time
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
cumulative 24 hours opioid consumption
Description
the total amount of opioid consumed by the patient in the first 24 hours postoperative
Time Frame
24 hours
Title
presence of any complications
Description
presence of any complications such as urine retention,vomiting ,respiratory depression
Time Frame
24 hours
Title
Mean arterial blood pressure
Description
intraoperative mean arterial blood pressure
Time Frame
evey 10 minutes intraoperative till end of surgery (up to 2 hours)
Title
Heart rate
Description
intraoperative heart rate
Time Frame
every 10 minutes intraoperative till end of surgery(up to 2 hours)
Title
VAS score
Description
The visual analog score (VAS) is a validated,subjective measure for acute and chronic pain.scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain"
Time Frame
at 15 & 30 mins, then at 2, 6, 12, 24 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing Lumbar spine surgery (L1-L5). American society of anesthesiologists classification (ASA) I and II. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed F mohamed, ass prof.
Organizational Affiliation
Anesthesia department , Cairo university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gomaa Z Hussein, professor
Organizational Affiliation
Anesthesia department , Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy Hospitals
City
Giza
State/Province
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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