Local Analgesia Via Infiltration, Caudal Epidural Anesthesia, Caudal Block, Caudal Block for Postoperative Analgesia, Caudal Anesthesia, Erector Spinae Plane Block, Children
Conditions
Keywords
Erector Spinae Block, Caudal Block, Pediatrics, llower abdominal surgery
Brief summary
The goal of this prospective study is to is to evaluate the perioperative pain management of Erector Spinae Block versus Caudal Block using the Face, Legs, Activity, Cry, Conceal ability (FLACC) Pain Scale inn children aged 2 to 7 years old. The main question it aims to answer is: Which block is more efficient in the perioperative period? Participants will be evaluated intraoperative and postoperative for hemodynamic changes and their pain will evaluated according to the FLACC score.
Interventions
Ultrasound Guided Erector Spinae Plane block given bilaterally at level of L1.
PROCEDURECaudal Block Anesthesia
Ukltrasound Guided Caudal Epidural Block
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 2-7 years old. * ASA I-II. * Elective surgery under general anaesthesia. * Lower abdominal surgery.
Exclusion criteria
* Parent/caregiver refusal. * Allergy to one of the study medications. * Renal or cardiac disease. * Infection or redness at the site of injection. * Clinically significant coagulopathy. * Spinal anomalies. * Altered mental status. * Developmental delay. * Additional surgery at different surgical sites. * Block failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block. | At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery. | Evaluate postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. A score of 0 = no pain, 10 = severe pain. A score ≥4 requires rescue analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to first rescue analgesic. | from 0 to 8 hours after block administration | Time from block administration to the patient's first requirement for rescue analgesia. |
| Total postoperative analgesic requirements. | from 0 to 8 hours after block administration | Amount and frequency of analgesia patient requested |
| Parent satisfaction with a 5-point Likert scale questionnaire. | At 8 hours after block administration | Parent or caregiver satisfaction about block efficiency on a scale of 1 to 5. |
| Number of patients required rescue analgesic postoperatively. | From 0 to 8 hours after surgery. | Number of patiebts of asked for rescue analgesia is recorded. |
| Changes to heart rate (beats/minute) | T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery | Changes to heart rate (beats/minute) recorded before surgery, during surgery and immediately after surgery |
| Incidence of any adverse effects. | from end of surgery (0 hours) to 8 hours postoperatively | Any side effects reported by the patient related to analgesia. |
| Changes to mean arterial pressure (MAP) | T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery | changes to mean arterial pressure (MAP) (mmHg) before surgery, during surgery and immediately after surgey |
| Changes to oxygen saturation | T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery | Changes to oxygen saturation before surgery, during surgery and immediately after surgery. |
| Time to Modified Aldrete score ≥9. | from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes) | Postoperative recovery was assessed using the Modified Aldrete Scoring System, which evaluates five physiological criteria: activity, respiration, circulation, consciousness, and oxygen saturation |
Countries
Egypt
Outcome results
None listed