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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Determining the total amount of fentanyl that will be consumed as intra operative analgesia
Study Overview
Brief 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.
Detailed Description
- The clinical trial will justify the current practice of combined continuous caudal epidural with general anaesthesia in adult patients undergoing lumbar fixation versus general anaesthesia and using this clinical trial to prove the good analgesic effect of continous caudal epidural and its use to decrease opioid use intra and post operative.
- This clinical trial can trace intra and post operative hemodynamic changes while using continuous caudal epidural.
- This clinical trail will record the possible complications and their incidence of continuous caudal epidural.
- Sample size justification: the expected mean intra-operative narcotic consumption among study groups is 186.5 ± 21.6 µg and 106 ± 16.4 µg.
Sample size of 30 patients per group can detect the difference between two groups with power >90% and alpha error 0.05.
- Statistical analysis: this clinical trial will be carried out using the statistical software program. Description of quantitative data as mean and standard deviation and qualitative data as number and percentage.Comparison between the two groups will be done by using the Chi-square test, independent t-test or Mann-Whitney U-test according to the distribution of data. A p-value less than 0.05 will be considered statistically significant.
- Study Procedures:
Patients will be randomly allocated into two equal groups.
Preoperative setting:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age group: Adult patients from age of 21 years to 60 years
- •Sex: Both sexes.
- •American Society Association Classification (ASA): patients with ASA classification I, II.
- •Elective lumbar fixation surgeries.
Exclusion Criteria
- •Patients refuse to give informed consent.
- •Patients younger than 21 or older than
- •History of bupivacaine allergy.
- •Emergency surgeries.
- •Patients who underwent previous spine surgeries of any cause.
- •Infection at the site of injection.
- •Coagulopathy (acquired, induced, genetic).
- •ASA Classification: ASA III, IV.
- •Severe aortic stenosis, severe mitral stenosis, hypertrophic obstructive cardiomyopathy.
- •Severe hypovolemia, Severe uncorrected anemia.
- •Increased intra-cranial pressure (i.e., brain tumor or recent head injury).
Arms & Interventions
Combined continuous caudal epidural and general anaesthesia
-Patients will be located in the prone position for caudal epidural block.Fluoroscopy will be utilized and a lateral view will be obtained to demonstrate the anatomic boundaries of the sacral canal. 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.
Intervention: Combined continous caudal epidural with general anaesthesia (Other)
General anaesthesia (opioid analgesia)
-General anaesthesia will be induced with administration of extra doses of fentanyl as needed according to hemodynamic changes suggesting pain sensation
Intervention: Combined continous caudal epidural with general anaesthesia (Other)
Outcomes
Primary Outcomes
Determining the total amount of fentanyl that will be consumed as intra operative analgesia
Time Frame: during intraoperative period (from induction of anesthesia until recovery from general anaesthesia)
the amount of fentanyl on micrograms used intra operative for both groups
Secondary Outcomes
- Determining the total amount of morphine that will be given as analgesia(the first 6 hours post operative)
- Analyzing the numeric pain scale score(the first 6 hours post operative)
- Detecting effect of continuous caudal epidural analgesia on intra operative and post operative on vital data (using heart rate)(intra operative and the first 6 hours post operative)
- Identifying the time to the first demand for rescue analgesia(any time during the first 6 hours post operative)
Investigators
Esraa Abdellatif
Assistant lecturer of anesthesia, intensive care unit and pain management
Ain Shams University