Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

Pediatric Hip Surgery Clinical Trial

Official title:

Comparison of Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712370
• Other study ID #: 33143/05/19
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: January 2021
• Source: Tanta University
• Contact: Eman Hamdy Abu-Shanab, MSc
• Phone: +201005518097
• Email: eman.hamdy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 10, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Both sex

• ASA physical activity I, II

• Age 4-12 years

• Admitted for elective hip surgery.

Exclusion Criteria:

• Parents refusal

• Children with severe systemic disease

• ASA III or IV

• Children with previous neurological or spinal anomaly, coagulation disorders

• History of premature birth

• Infection at the block injection site

• History of allergy to local anesthetics

• Bilateral hip surgery.

Related Conditions & MeSH terms

• Conventional Caudal Block
• Pediatric Hip Surgery
• Ultrasound Guided Caudal Block
• Ultrasound Guided Erector Spinae Block

Intervention

Procedure:
• Conventional caudal block
Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).
• Ultrasound-guided caudal block
Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).
• Ultrasound guided erector spinae plane Block
Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of pain intensity	To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)	First 24 hours postoperative
Secondary	Changes in mean arterial blood pressure	Mean arterial blood pressure will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).	Intraoperative and first 24 hours postoperative
Secondary	Changes in heart rate	Heart rate will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).	Intraoperative and first 24 hours postoperative
Secondary	Amount of Analgesic required in the first day after surgery	The total dose of intravenous (IV) acetaminophen 15 mg/kg if FLACC scores between 2 and 4 at the first 24 h after surgery, and total dose of tramadol 1 mg/kg (IV) in case of FLACC score > 4.	First 24 hours postoperative
Secondary	Time to first rescue analgesic demand after surgery.	measured from the end of surgery till patient require analgesia.	First 24 hours postoperative
Secondary	Success rate of block	a successful block is defined as absence of significant changes in heart rate following surgical induction. Heart rate increase is not>20% of the basal levels. If the increase is>20%, the block is accepted as unsuccessful.	Intraoperative duration
Secondary	Duration of performing the block	Block performing time is defined as the period between the insertion of the needle and termination of local anesthetic administration	Intraoperative duration
Secondary	Incidence of complications	Hypotension, bradycardia, postoperative nausea, vomiting, urinary retention, prolonged motor block, pruritus and local anesthetic systemic toxicity (LAST).	Intraoperative and first 24 hours postoperative