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OpenTrials
Completed

NCT Number: NCT04790318

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

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.

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Key information

Conditions

Anesthesia

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • - patients whose guardians refuse to participate.
  • -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.

Treatment and study plan

Trans-incisional Quadratus lumborum block

Procedure

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

Procedure

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.

Primary outcomes

  1. First time to analgesic requirement

    Time frame: 1st 24 hour

    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.

Secondary outcomes

  1. total analgesic consumption

    Time frame: 1st 24 hour

    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 .

  2. Face, leg, activity, cry, consolability scale (FLACC)

    Time frame: 1st 24 hours postoperatively

    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).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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