Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery

Anesthesia, Local Clinical Trial

Official title:

Comparing Analgesic Effects of Ultrasound-Guided Caudal and Erector Spinae Plane Blocks in Pediatric Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Double-Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204343
• Other study ID #: 2018/1073
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 25, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Description:

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• undergoing upper abdominal surgery

• ASA(American Society of Anesthesiology)1-2

Exclusion Criteria:

• denial of patient or parents

• infection on the local anesthetic application area

• infection in the central nervous system

• coagulopathy

• brain tumors

• known allergy against local anesthetics

• anatomical difficulties

• with preexisting cardiac dysfunction

• with history of renal and/or hepatic dysfunction

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• Bupivacaine 0.7 ml/kg
Bupivacaine 0.25% 0.7 ml/kg
• Bupivacaine 0.5 ml/kg
Bupivacaine 0.25% 0.5 ml/kg

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale	Pain scores between 0-10	up to 48 hours
Secondary	length of hospital stay	hospitalisation	through study completion, an average of 1 week
Secondary	number patients who require rescue analgesic	number of patients who require IV morphine (0.03 mg/kg) during the first 2 hours and paracetamol in the 48 hours	up to 48 hours
Secondary	Time to first analgesic	Duration of postoperative analgesia	up to 48 hours
Secondary	Incidence of side effects/complications	hematoma, dural puncture, infections	up to first week
Secondary	Time to first mobilization	time to first mobilization	up to 48 hours
Secondary	Presence of pain (chronic pain - Visual Analog scale>3)	Chronic pain due to incision after 2-3 months	3 months

External Links

•   Caudal Epidural Block: An Updated Review of Anatomy and Techniques.
•   Erector Spinae Plane Block in Management of Pain After Kidney Transplantation.
•   Expert opinion: regional nerve blocks in everyday pediatric urology: 2. Ultrasound-guided regional anesthetic caudal block.
•   The Erector Spinae Plane Block.
•   Ultrasound-Guided Single-Shot Preemptive Erector Spinae Plane Block for Postoperative Pain Management.