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

Primary Purpose

Postoperative Pain, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
caudal epidural block
bilateral erector spinae plane block
general anesthesia with intravenous analgesia.
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain, Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group (CE): Patients receiving caudal epidural block

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

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

Arm Description

Outcomes

Primary Outcome Measures

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').
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')
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')
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')
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')

Secondary Outcome Measures

intraoperative mean arterial blood pressure
measured by non invasive blood pressure monitoring
intraoperative heart rate
measured by twelve leads electrocardiogram
postoperative first rescue analgesia time
Surgical field bleeding.
using Fromme score assessed by the surgeon 6-point scale Endoscopic surgical field grading system Grade Assessment 0 No bleeding (cadaveric conditions) Slight bleeding, no suctioning required Slight bleeding, occasional suctioning required Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
Number of participant with postoperative nausea
Number of participant with postoperative vomiting
Number of participant with postoperative urinary retention

Full Information

First Posted
January 28, 2023
Last Updated
February 6, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05729308
Brief Title
Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Lumbosacral Spine Surgeries.
Official Title
Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Adult Patients Undergoing Lumbosacral Spine Surgeries.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
Detailed Description
78 Participants undergoing lumbosacral spine surgeries who met the inclusion criteria will be divided into three groups each group contains 26 patients: Group (CE): Patients receiving caudal epidural block. Group (ESP): Patients receiving bilateral erector spinae plane block. Group (C): Control group, patients receiving general anesthesia with intravenous analgesia. • Study procedures: Routine preoperative assessment will be done for all the participants. All participants will be fasting before the procedure not less than 6 hours. General anesthesia will be induced with midazolam (0.05mg/kg), propofol (1.5-2mg/kg), fentanyl (1-2μg/kg) and atracurium (0.5mg/kg), Tracheal intubation will be performed. After induction, general anesthesia will be maintained with a volatile anesthetic agent (0.9:1.2% isoflurane) and controlled ventilation with atracurium every 20 mins (0.1 mg/kg). Standard monitoring of mean arterial blood pressure (MAP), heart rate (HR) and peripheral pulse oximeter (SPO2) value will be monitored at time of induction (time 0) and every 10 minutes till the end of the procedure. Group (CE): Caudal epidural group 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 megahertz 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 (ES): Erector spinae group 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(C): General anesthesia with conventional 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. After completion of the surgical procedure, patient will be in supine position, isoflurane will be discontinued and fresh gas flow will be increased and any residual neuromuscular blockade will be reversed by I.V neostigmine 50 μg/kg (to a maximum of 5 mg) plus atropine 10-20 μg/kg. Any blood and secretions in the pharynx will be carefully suctioned. Tracheal extubation will be performed when the patient regained consciousness, has sufficient spontaneous breathing, intact gag reflex, purposeful movement, and spontaneous eye opening. After extubation in the three groups, the patients will be transferred to the postanesthesia care unit and will be monitored as mentioned above. The visual analog score (VAS) is a validated, subjective measure for acute pain. Scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain". VAS score will be assessed at 15 & 30 mins, then at 2, 6, 12, 24 hours post-operatively. Rescue pain analgesia will be given postoperatively for visual analogue scale (VAS)≥4 by nalbuphine hydrochloride (Nalufin)10-20 mg/70kg IV q3-6hr on demand; individual dose not to exceed 20 mg). VAS will be reassessed 15 minutes later to any post analgesic injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (CE): Patients receiving caudal epidural block
Arm Type
Active Comparator
Arm Title
Group (ESP): Patients receiving bilateral erector spinae plane block.
Arm Type
Active Comparator
Arm Title
Group (C): Control group, patients receiving general anesthesia with intravenous analgesia.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
caudal epidural block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
bilateral erector spinae plane block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
general anesthesia with intravenous analgesia.
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative analgesia
Description
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').
Time Frame
immediately postoperative
Title
postoperative analgesia
Description
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')
Time Frame
2 hours postoperative
Title
postoperative analgesia
Description
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')
Time Frame
6 hours postoperative
Title
postoperative analgesia
Description
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')
Time Frame
12 hours postoperative
Title
postoperative analgesia
Description
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')
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
intraoperative mean arterial blood pressure
Description
measured by non invasive blood pressure monitoring
Time Frame
every 10 minutes intraoperative till end of surgery
Title
intraoperative heart rate
Description
measured by twelve leads electrocardiogram
Time Frame
every 10 minutes intraoperative till end of surgery
Title
postoperative first rescue analgesia time
Time Frame
during the 24 hours postoperative
Title
Surgical field bleeding.
Description
using Fromme score assessed by the surgeon 6-point scale Endoscopic surgical field grading system Grade Assessment 0 No bleeding (cadaveric conditions) Slight bleeding, no suctioning required Slight bleeding, occasional suctioning required Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
Time Frame
from the start till the end of the operation
Title
Number of participant with postoperative nausea
Time Frame
during the 24 hours postoperative
Title
Number of participant with postoperative vomiting
Time Frame
during the 24 hours postoperative
Title
Number of participant with postoperative urinary retention
Time Frame
during the 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for lumbosacral spine surgery level from L4 to S1. American Society of Anesthesiologists classification (ASA) class I or II. Exclusion Criteria: 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
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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