Lateral Versus Posterior Quadratus Lumborum Block in The Pediatric Patients Undergoing Orchiopexy
- Conditions
- Pain
- Interventions
- Procedure: Lateral Quadratus Lumborum blockProcedure: Posterior Quadratus Lumborum Block
- Registration Number
- NCT05056038
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Brief Summary
There is a complex innervation of the testis and spermatic canal, and many different regional analgesia methods can be used for pain occurring during and after undescended testicular surgery. Quadratus lumborum block (QLB) can be count as the one of the primary method to manage the pain.
In this study, our primary aim will be to compare the effects of lateral and posterior QLB application on perioperative and postoperative pain and analgesic use in pediatric patients who will undergo unilateral elective undescended testicular surgery. Our secondary aim will be to compare patient and family satisfaction and complications.
- Detailed Description
American Society of Anesthesiologists Physical Status Classification System (ASA) class I-III, aged 6 month-12 years old children undergoing unilateral elective orchiopexy with general anesthesia will be recruited, after the informed consent will be obtained from the parents of the patients, in this triple blind randomized controlled trial.
After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane.
Subsequently, before the surgery, the patients will be randomized and separated into 2 groups. The investigators will apply the lateral QLB to the first group and posterior QLB to the other group. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both group.
In the peroperative period, if the additional analgesia will necessary, remifentanyl 0.1mcg/kg/min will be started, and dosage will be adjusted according to heart rate and blood pressure. If the blood pressure or heart rate will increase more than 20% from the preoperative basal value will be defined as the need for the analgesia.
In the postoperative period, all cohort will be assessed by a blinded investigator at the 10,20,30th minutes, 1,2nd hours in the recovery room, 6th hour in the surgical ward, Face, Legs, Activity, Cry, Consolability Scale (FLACC) will be used for the pain evaluation. 16th and 24th hours will be monitored by the telephone visit from the parents, the pain will be evaluated with the Wong-Baker Faces Pain Rating Scale due to the same-day surgery concept.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 103
- ASA physical status I-III
- Undergoing elective unilateral orchiopexy
- Not giving a consent
- Regional anesthesia contraindications
- ASA physical status IV
- Need to postoperative ICU care
- Laparoscopic orchiopexy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lateral Quadratus Lumborum Block Lateral Quadratus Lumborum block After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bıçakçılar Cooperation, Istanbul, Turkey) according to age and body weight. Posterior Quadratus Lumborum Block Posterior Quadratus Lumborum Block After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the posterior border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bıçakçılar Cooperation, Istanbul, Turkey) according to age and body weight.
- Primary Outcome Measures
Name Time Method Perioperative and Postoperative Total Analgesia Consumption 24 hour The perioperative necessity of the additional analgesia was determined as the 20% increase of the heart rate and blood pressure values from the basal level and the dose of the remifentanyl was adjusted according to this protocol. The Face Legs Activity Cry Consobility (FLACC) Score will be used in hospital. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned. For the evaluation of the post-discharge, Wong Baker Pain score will be used. According to Wong Baker Score Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.
The Effect on Perioperative and Postoperative Pain 24 hour The Face Legs Activity Cry Consobility (FLACC) Score will be used in hospital. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned. For the evaluation of the post-discharge, Wong Baker Pain score will be used. According to Wong Baker Score Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.
- Secondary Outcome Measures
Name Time Method Complications 24 hour The investigators will screen and record the complications such as nausea, vomiting, haematoma, solid organ injury, etc.
Parent satisfaction score 24 hour At the postoperative 24th hour, the investigator will ask to the parents by telephone visit. Parent satisfaction score is defined as unsatisfied (1), partially satisfied (2), satisfied (3).
Trial Locations
- Locations (1)
Istanbul University - Cerrahpasa
🇹🇷Istanbul, Turkey