Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries.

Anesthesia Clinical Trial

Official title:

Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries, a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790318
• Other study ID #: FMASU R 48/2020/2021
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: October 20, 2022

Study information

• Verified date: December 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is scare literature about the usage of QLB in pediatric population, particularly the trans-incisional approach. Hence, the purpose of this study is to compare the postoperative analgesic efficacy of ultrasound-guided caudal epidural block versus ultrasound-guided QLB (trans-incisional) in combination with general anesthesia in pediatric patients undergoing elective open renal surgeries regarding pain scores, total analgesic consumption, and adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

Inclusion Criteria:

1. patients who will be scheduled for indicated open pediatric renal surgery in the lateral decubitus position (nephrectomy, partial nephrectomy, pyeloplasty and nephrolithotomy for complex renal stones).

2. physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

1. - patients whose guardians refuse to participate.

2. -ASA physical status >II. 3-patients who have contraindications to regional analgesic procedures. 4-patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological).

5-spine or chest wall deformity. 6-History of previous renal surgeries. 7-Coagulation abnormalities. 8-Infection at the injection site. 9-An allergy or contraindications to the drugs used in the study.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Trans-incisional Quadratus lumborum block
patients will receive combined general anesthesia and quadratus lumborum block (trans-incisional) with 0.5 mL/kg of bupivacaine 0.2 %. with maximum volume was limited to 20 ml
• Caudal block
patients will receive combined general anesthesia and caudal analgesia (just after wound closure) with 1.25 mL/kg of bupivacaine 0.2 % (three parts 0.25 % bupivacaine to one part saline.

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First time to analgesic requirement	Ketorolac is an IV NSAID that has been shown to have similar efficacy to morphine . Ketorolac will be dosed at 0.5 mg/kg every 6-8 hours for the 1st 24 h postoperatively as an analgesic after request.	1st 24 hour
Secondary	total analgesic consumption	Ketorolac will be dosed at 0.5 mg/kg every 6-8 hours for the 1st 24 h postoperatively as an analgesic after request.Total ketorolac consumption per 24 h will be calculated .	1st 24 hour
Secondary	Face, leg, activity, cry, consolability scale (FLACC)	Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU and 10, 20, and 30 min and 1, 2, 4, 6, 12, and 24 h thereafter using the face, leg, activity, cry, consolability scale (FLACC) (ranging from 0-10, where 0 = no pain, 10 = worst pain).	1st 24 hours postoperatively