Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy

Pediatrics Clinical Trial

Official title:

Ultrasound Guided Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452225
• Other study ID #: 36264PR641/4/24
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Tanta University
• Contact: Mohammed S ElSharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.

Description:

Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.

External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Both sexes.

• American Society of Anesthesiology (ASA) physical status I-III.

• Scheduled for open nephrectomy.

Exclusion Criteria:

• Abnormal blood coagulation.

• Scar, infection, and tumor of puncture site.

• History or family history of high malignant fever.

• Severe cardiovascular problems.

Related Conditions & MeSH terms

• Pediatrics
• Postoperative Analgesia
• Transversus Abdominis Plane Block

Intervention

Other:
• External Oblique Intercostal Plane Block
Patients will receive external oblique intercostal plane block.
• Transversus Abdominis Plane Block
Patients will receive ultrasound guided transversus abdominis plane block.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Every 15 minutes till the end of surgery
Primary	Time to the 1st rescue analgesia	A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 15 mg /kg/8 hrs as routine analgesia. Rescue analgesia of morphine will be given as 0.05 mg/kg if face, legs, activity, and cry consolability scale (FLACC) = 4 and the maximum allowed dose is 0.1mg/kg every 4 hours. FLACC will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively.; it will be measured from the end of surgery to first dose of morphine administrated.	24 hours postoperatively
Secondary	Intraoperative fentanyl consumption	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).	Intraoperatively
Secondary	Total morphine consumption	Rescue analgesia of morphine will be given as 0.05 mg/kg if the face, legs, activity, and cry consolability scale (FLACC) = 4 and the maximum allowed dose is 0.1mg/kg every 4 hours.	24 hours postoperatively
Secondary	Degree of pain	The pain will be assessed by using the face, legs, activity, and cry consolability scale (FLACC). The level of response for each observation is given a numerical value rating from "0" to "2," with "0" being the most comfortable with no pain and "2" being the most painful , which results in a total score between "0" and "10".; It will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively.	24 hours postoperatively
Secondary	Mean arterial pressure	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Every 15 minutes till the end of surgery