Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584292
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Comparison of Caudal Block and Retrolaminar Block for Circumcision
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Caudal Block and Retrolaminar Block for Postoperative Analgesia in Concurrent Circumcision and Low Abdominal Surgery in Pediatric Patients A Double-blind Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Outcome
Analgesic Efficiency The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block RL versus caudal block CB based on postoperative pain scores measured by the FLACC score This outcome aims to evaluate how effectively each block controls postoperative pain
Secondary Outcomes
Analgesic Requirements
The amount of analgesic required within the first 24 hours postoperatively The time to the first analgesic requirement These will be recorded during postoperative follow-up visits at 30 minutes 1 2 4 6 12 and 24 hours by an anesthesiologist who is blinded to the study groups
Postoperative Complications
Urinary Retention Defined as a distended palpable bladder associated with pain
Motor Block The presence of lower extremity motor block will be evaluated using the modified Bromage scale 0 No motor block 1 Able to move the legs 2 Unable to move the legs
Ecchymosis and Hematoma The presence of ecchymosis discoloration of the skin due to blood infiltration in the subcutaneous tissues and hematoma abnormal swelling or hardening caused by the accumulation of blood at the injection site will be assessed
Analgesic Efficiency The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block RL versus caudal block CB based on postoperative pain scores measured by the FLACC score This outcome aims to evaluate how effectively each block controls postoperative pain
Secondary Outcomes
Analgesic Requirements
The amount of analgesic required within the first 24 hours postoperatively The time to the first analgesic requirement These will be recorded during postoperative follow-up visits at 30 minutes 1 2 4 6 12 and 24 hours by an anesthesiologist who is blinded to the study groups
Postoperative Complications
Urinary Retention Defined as a distended palpable bladder associated with pain
Motor Block The presence of lower extremity motor block will be evaluated using the modified Bromage scale 0 No motor block 1 Able to move the legs 2 Unable to move the legs
Ecchymosis and Hematoma The presence of ecchymosis discoloration of the skin due to blood infiltration in the subcutaneous tissues and hematoma abnormal swelling or hardening caused by the accumulation of blood at the injection site will be assessed
Detailed Description:
This study is a double-blind randomized controlled trial designed to compare the analgesic efficacy and safety of the retrolaminar block RL versus the caudal block CB in pediatric patients undergoing concurrent circumcision and lower abdominal surgery The trial adheres to the ethical principles outlined in the Declaration of Helsinki and was conducted in the Anesthesiology and Reanimation department of a tertiary education and research hospital
Study Population The study included pediatric patients aged 1 to 7 years who were classified as American Society of Anesthesiologists ASA physical status I or II These patients were scheduled for elective unilateral lower abdominal surgery such as orchiopexy or hydrocelectomy combined with circumcision The inclusion criteria ensured the selection of otherwise healthy children with no significant comorbidities Exclusion criteria included patients younger than 1 year or older than 7 years those with neurological deficits bleeding disorders allergy to local anesthetics infection at the injection site congenital spinal anomalies intellectual disabilities psychiatric disorders liver andor kidney diseases and those who declined to participate
Randomization and Blinding Participants were randomly assigned to one of two groups RL block or CB block using a computer-generated randomization table The randomization process was designed to ensure an equal distribution of patients across both groups Both patients and the healthcare professionals involved in postoperative care were blinded to the type of block administered To maintain blinding both blocks were performed under sterile conditions and identical transparent drapes were used to cover the injection sites An anesthesiologist who was not involved in the block administration was responsible for data collection related to postoperative analgesic requirements and complications
General Anesthesia Protocol All patients received 05 mgkg of oral midazolam as premedication In the operating room standard monitoring was applied and anesthesia was induced with intravenous IV propofol 2 mgkg and fentanyl 05 µgkg After the loss of the eyelash reflex an appropriately sized laryngeal mask airway LMA was placed without the use of neuromuscular blocking agents Anesthesia was maintained with sevoflurane 2 in a mixture of 50 oxygen and air Demographic data including age weight type of surgery duration of the procedure and any complications were recorded
Regional Anesthesia Procedure Following the induction of general anesthesia and airway management the patients were placed in the left lateral decubitus position for the regional block procedure All blocks were performed by a single experienced operator skilled in pediatric ultrasound-guided regional anesthesia using a 22-G 50-mm echogenic needle The ultrasound guidance was provided by a high-frequency 65-18 MHz linear probe
Caudal Block CB Procedure The sacral hiatus was identified using an out-of-plane transverse ultrasound view at the level of the sacral cornua The probe was then rotated longitudinally to visualize the sacrococcygeal ligament and sacral bone A block needle was inserted through the sacrococcygeal membrane into the sacral canal using the in-plane technique and 0125 bupivacaine was administered at a dose of 1 mLkg with a maximum limit of 20 mL per side
Retrolaminar Block RL Procedure The RL block was performed with the patient in a lateral decubitus position The ultrasound probe was positioned at the L4 vertebral level in a paramedian sagittal plane The probe was moved medially until the vertebral laminae were visualized The needle was inserted using the in-plane technique advancing from the cephalad to caudal direction until it contacted the L4 lamina A dose of 01 mLkg of 025 bupivacaine was then injected into the retrolaminar space
Both blocks were administered bilaterally and the patients were repositioned supine 15 minutes before the start of the surgery
Postoperative Monitoring and Follow-up Postoperative monitoring included heart rate non-invasive blood pressure and peripheral oxygen saturation These parameters were recorded before and after the block every 5 minutes The effectiveness of the block was assessed based on changes in heart rate and blood pressure following the surgical incision An increase of 20 or more in these values was considered indicative of an unsuccessful block in which case a rescue dose of fentanyl 05 µgkg IV was administered
In the recovery room and at the ward postoperative pain was evaluated using the FLACC scale at predefined intervals 30 minutes 1 2 4 6 12 and 24 hours The requirement for rescue analgesia was based on the FLACC scores with IV paracetamol administered for scores of 2 to 4 and IV tramadol for scores above 4 Additionally postoperative complications such as urinary retention motor block and the presence of ecchymosis or hematoma at the injection site were documented by the anesthesiologist blinded to the block type
Data Collection and Statistical Analysis Demographic characteristics surgical details analgesic requirements and postoperative complications were systematically recorded The data were analyzed using IBM SPSS Statistics for Windows Version 220 Normality of data distribution was assessed using the Shapiro-Wilk test and appropriate statistical tests were applied based on data distribution Studentamp39s t-test for normally distributed data Mann-Whitney U test for non-parametric data and Chi-square or Fishers exact test for categorical data Effect sizes were calculated using the Cohen method and a p-value of less than 005 was considered statistically significant
Randomization and Blinding Randomization was performed using a computer-generated randomization table httpwww randomorg and patients were divided into two groups RL and CB The nurse was blinded to the face legs activity cry and consolability FLACC scores An anesthesiologist was blinded to data collection regarding analgesic requirement and postoperative complications Transparent sterile drapes were applied to the injection sites and both blocks were administered to all patients to evaluate postoperative complications Thus the anesthetist was blinded to the postoperative complications
Study Population The study included pediatric patients aged 1 to 7 years who were classified as American Society of Anesthesiologists ASA physical status I or II These patients were scheduled for elective unilateral lower abdominal surgery such as orchiopexy or hydrocelectomy combined with circumcision The inclusion criteria ensured the selection of otherwise healthy children with no significant comorbidities Exclusion criteria included patients younger than 1 year or older than 7 years those with neurological deficits bleeding disorders allergy to local anesthetics infection at the injection site congenital spinal anomalies intellectual disabilities psychiatric disorders liver andor kidney diseases and those who declined to participate
Randomization and Blinding Participants were randomly assigned to one of two groups RL block or CB block using a computer-generated randomization table The randomization process was designed to ensure an equal distribution of patients across both groups Both patients and the healthcare professionals involved in postoperative care were blinded to the type of block administered To maintain blinding both blocks were performed under sterile conditions and identical transparent drapes were used to cover the injection sites An anesthesiologist who was not involved in the block administration was responsible for data collection related to postoperative analgesic requirements and complications
General Anesthesia Protocol All patients received 05 mgkg of oral midazolam as premedication In the operating room standard monitoring was applied and anesthesia was induced with intravenous IV propofol 2 mgkg and fentanyl 05 µgkg After the loss of the eyelash reflex an appropriately sized laryngeal mask airway LMA was placed without the use of neuromuscular blocking agents Anesthesia was maintained with sevoflurane 2 in a mixture of 50 oxygen and air Demographic data including age weight type of surgery duration of the procedure and any complications were recorded
Regional Anesthesia Procedure Following the induction of general anesthesia and airway management the patients were placed in the left lateral decubitus position for the regional block procedure All blocks were performed by a single experienced operator skilled in pediatric ultrasound-guided regional anesthesia using a 22-G 50-mm echogenic needle The ultrasound guidance was provided by a high-frequency 65-18 MHz linear probe
Caudal Block CB Procedure The sacral hiatus was identified using an out-of-plane transverse ultrasound view at the level of the sacral cornua The probe was then rotated longitudinally to visualize the sacrococcygeal ligament and sacral bone A block needle was inserted through the sacrococcygeal membrane into the sacral canal using the in-plane technique and 0125 bupivacaine was administered at a dose of 1 mLkg with a maximum limit of 20 mL per side
Retrolaminar Block RL Procedure The RL block was performed with the patient in a lateral decubitus position The ultrasound probe was positioned at the L4 vertebral level in a paramedian sagittal plane The probe was moved medially until the vertebral laminae were visualized The needle was inserted using the in-plane technique advancing from the cephalad to caudal direction until it contacted the L4 lamina A dose of 01 mLkg of 025 bupivacaine was then injected into the retrolaminar space
Both blocks were administered bilaterally and the patients were repositioned supine 15 minutes before the start of the surgery
Postoperative Monitoring and Follow-up Postoperative monitoring included heart rate non-invasive blood pressure and peripheral oxygen saturation These parameters were recorded before and after the block every 5 minutes The effectiveness of the block was assessed based on changes in heart rate and blood pressure following the surgical incision An increase of 20 or more in these values was considered indicative of an unsuccessful block in which case a rescue dose of fentanyl 05 µgkg IV was administered
In the recovery room and at the ward postoperative pain was evaluated using the FLACC scale at predefined intervals 30 minutes 1 2 4 6 12 and 24 hours The requirement for rescue analgesia was based on the FLACC scores with IV paracetamol administered for scores of 2 to 4 and IV tramadol for scores above 4 Additionally postoperative complications such as urinary retention motor block and the presence of ecchymosis or hematoma at the injection site were documented by the anesthesiologist blinded to the block type
Data Collection and Statistical Analysis Demographic characteristics surgical details analgesic requirements and postoperative complications were systematically recorded The data were analyzed using IBM SPSS Statistics for Windows Version 220 Normality of data distribution was assessed using the Shapiro-Wilk test and appropriate statistical tests were applied based on data distribution Studentamp39s t-test for normally distributed data Mann-Whitney U test for non-parametric data and Chi-square or Fishers exact test for categorical data Effect sizes were calculated using the Cohen method and a p-value of less than 005 was considered statistically significant
Randomization and Blinding Randomization was performed using a computer-generated randomization table httpwww randomorg and patients were divided into two groups RL and CB The nurse was blinded to the face legs activity cry and consolability FLACC scores An anesthesiologist was blinded to data collection regarding analgesic requirement and postoperative complications Transparent sterile drapes were applied to the injection sites and both blocks were administered to all patients to evaluate postoperative complications Thus the anesthetist was blinded to the postoperative complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None