CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Combined continous caudal epidural with general anaesthesiaother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06929611
NCT06929611N/ACompleted

Comparative Study of the Effect of Continuous Caudal Epidural With General Anaesthesia Versus General Anaesthesia on Intra Operative and Post Operative Analgesic Requirements for Lumbar Fixation

Ain Shams University·interventional·Posted Apr 16, 2025·Updated Apr 16, 2025

In Brief

A clinical study evaluating Combined continous caudal epidural with general anaesthesia for Analgesia. Completed, enrolled 60 participants across 1 site.

Detailed Summary

In this clinical study, the investigators will justify the current practice of combined continuous caudal epidural with general anaesthesia in adult patients undergoing lumbar fixation versus general anaesthesia. Furthermore, the investigators will determine the analgesic requirement, rescue analgesia, hemodynamic changes and possible complications with continuous caudal epidural analgesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnalgesia
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedApr 16, 2025
Enrollment StartJan 15, 2024
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.2 years ago

Interventions

Combined continous caudal epidural with general anaesthesiaother

A 17- or 18-gauge Tuohy-type needle will be inserted in the midline into the caudal canal. An initial dose of 20 ml of 0.25% bupivacaine will be injected in the caudal canal in order to perform sensory block and spare motor power. Then a dose of 10 ml 0.25% bupivacaine will be injected through the epidural catheter every 1-hour intra operatively and at 0-hour and 1-hour post operative then the catheter will be removed 1 hour post operative. -The following factors will be assessed: 1. Intra operative heart rate and blood pressure. 2. Post operative pain assessment according to numeric pain scale score. 3. Time to rescue analgesia (intravenous analgesia administered after surgery).Patients with numeric pain scale score ≥ 3 at any point of time, will receive intravenous morphine 5mg. 4. Estimated blood loss and surgeon satisfaction of surgical field. 5. Total intra operative and post operative analgesia. 6. Common complications.