search
Back to results

Erector Spinea Plane Block in Pediatric Hip Surgery

Primary Purpose

Postoperative Pain, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Real ultrasound-guided single shot erector spinae plane block (ESP B)
Sham ultrasound-guided single shot erector spinae plane block (ESP B)
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Erecto spinae plane, Hip surgery, Children, Pain, Morphine consumption

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study

Exclusion Criteria:

  1. Parental refusal.
  2. Preexisting spinal deformity or profound mental retardation.
  3. Obese Children
  4. Known or suspected allergy to local anesthetics.
  5. Known or suspected coagulopathy
  6. Major cardiac, renal, or hepatic disorders.
  7. Children undergoing combined or bilateral surgeries.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery without injection of local anesthetics

patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.

Outcomes

Primary Outcome Measures

Total morphine consumption in the first postoperative day
Calculation of the total dose of morphine consumed in the first day after surgery

Secondary Outcome Measures

The time to first request for rescue analgesia
The time interval from the end of the surgery till the first dose of morphine administrated
Postoperative pain score
The postoperative pain score (CHEOPS pain score)

Full Information

First Posted
May 1, 2020
Last Updated
February 2, 2021
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT04374396
Brief Title
Erector Spinea Plane Block in Pediatric Hip Surgery
Official Title
The Effect of Erector Spinea Plane Block on the Postoperative Analgesia in Pediatric Hip Surgery: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta 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
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to first request for rescue analgesia and postoperative pain score will be the secondary outcome. The study will be carried out on pediatric patients undergoing hip surgery where they will receive real or sham ultrasound guided erector spinae plane block before the onset of the surgery.
Detailed Description
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries. Primary outcome: Total morphine consumption in the first postoperative day. Secondary outcome: The time to first request for rescue analgesia and postoperative pain score. This clinical trial will be carried out in Tanta University Hospitals for a period of 6 month that may be extended on pediatric patients scheduled for surgical treatment of hip disorder under general anesthesia. A written informed consent will be obtained from the parents of all patients. Randomization will be performed by an independent data manager assigned the patients to groups based on a computer-generated randomization program introduced in closed opaque envelope. Group 1 (20 patients): patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at the level of second lumbar vertebra after induction of anesthesia and before the start of surgery without injection of local anesthetics. Group 2 (20 patients): patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block att the level of second lumbar vertebra after induction of anesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine. Anesthetic technique All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.5 mg/kg 15 minutes before admission to the operating room. Upon admission to the operating room, intravascular access will be obtained with starting i.v infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide, temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5 ug/kg will be given intravenously and atracurium 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and secured with connection of the patients to a mechanical ventilator (pressure-controlled mode) which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg. Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium. Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial pressure by more than 20% of the baseline values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Use
Keywords
Erecto spinae plane, Hip surgery, Children, Pain, Morphine consumption

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Prospective study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Sham ESP block will be administrated in the control group Measurements will be obtained by anesthetist not participating in the study and blinded to its group
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Sham Comparator
Arm Description
patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery without injection of local anesthetics
Arm Title
Group 2
Arm Type
Experimental
Arm Description
patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.
Intervention Type
Procedure
Intervention Name(s)
Real ultrasound-guided single shot erector spinae plane block (ESP B)
Intervention Description
ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected.
Intervention Type
Radiation
Intervention Name(s)
Sham ultrasound-guided single shot erector spinae plane block (ESP B)
Intervention Description
EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. No local anesthetics will be injected
Primary Outcome Measure Information:
Title
Total morphine consumption in the first postoperative day
Description
Calculation of the total dose of morphine consumed in the first day after surgery
Time Frame
The first 24 hours after surgery
Secondary Outcome Measure Information:
Title
The time to first request for rescue analgesia
Description
The time interval from the end of the surgery till the first dose of morphine administrated
Time Frame
The first 24 hours after surgery
Title
Postoperative pain score
Description
The postoperative pain score (CHEOPS pain score)
Time Frame
every 2 hours in the first 8 hours then every 4 hours till 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study Exclusion Criteria: Parental refusal. Preexisting spinal deformity or profound mental retardation. Obese Children Known or suspected allergy to local anesthetics. Known or suspected coagulopathy Major cardiac, renal, or hepatic disorders. Children undergoing combined or bilateral surgeries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Ismaiel, M.D
Organizational Affiliation
Lecturer of Anesthesia and Intensive Care, Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Abdullah, M.D
Organizational Affiliation
Assistant Professor of Anesthesia and Intensive Care, Tanta University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Once the study had been successfully completed, the data will be shared for other researchers.

Learn more about this trial

Erector Spinea Plane Block in Pediatric Hip Surgery

We'll reach out to this number within 24 hrs