Analgesic Requirements for Lumbar Fixation With General Anaesthesia Versus Continuous Caudal Epidural
NCT ID: NCT06929611
Last Updated: 2025-04-16
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-01-15
2024-06-30
Brief Summary
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Detailed Description
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* 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:
* Pre-operative assessment will be done by accurate history taking, full physical examination, laboratory and radiological investigations. including complete blood count (CBC), liver function test (LFT), kidney function test (KFT), prothrombin time (PT) and partial thromboplastin time (PTT) will be checked.
* All patient will be fasting for 8 hours pre operative.
* All patients will be informed about the study design, objectives and techniques.
* Informed consent will be signed by every patient prior to inclusion in the study.
* All patients will be educated about numeric pain scale score which 0 means no pain and 10 means worst imaginable pain.
Intraoperative setting:
* Standard perioperative monitoring will include pulse oximetry, electrocardiogram, end-tidal carbon dioxide measurement, inhaled volatile agent concentration and non-invasive blood pressure measurement.
* Baseline parameters such as oxygen saturation, systolic, diastolic and mean blood pressure, heart rate will be observed.
* Intravenous line will be inserted.
* For all patients, general anaesthesia will be induced by intravenous route using midazolam 0.04 mg/kg, fentanyl 1 µg/kg, propofol 2 mg/kg, atracurium 0.5 mg/kg.
* This will be followed by endotracheal intubation and mechanical ventilation. Maintenance of anaesthesia will be achieved by isoflurane 1.5% in oxygen and air (50:50) and atracurium 0.1 mg/kg every 20 minutes, so as to maintain end tidal carbon dioxide between 35 to 40 mm Hg.
* Intra operative heart rate and mean blood pressure will be recorded. Estimated blood loss will be determined.
Group A: (continuous caudal epidural with general anaesthesia "study group")
* After induction of anaesthesia as mentioned above, patients will be located in the prone position for caudal epidural block. Sterile skin preparation and draping of the entire region will be completed in the standard fashion.
* Fluoroscopy will be utilized and a lateral view will be obtained to demonstrate the anatomic boundaries of the sacral canal. With fluoroscopy, the caudal canal will appear as a translucent layer posterior to the sacral segments. The median sacral crest will be visualized as an opaque line posterior to the caudal canal. The sacral hiatus will be visualized as a translucent opening at the base of the caudal canal. The coccyx will be seen articulating with the inferior surface of the sacrum. A 17- or 18-gauge Tuohy-type needle will be inserted in the midline into the caudal canal. A feeling of a slight "snap" may be appreciated when the advancing needle pierces the sacrococcygeal ligament. Once the needle reaches the ventral wall of the sacral canal, it will be withdrawn and reoriented, directing it more cranially (by depressing the hub and advancing) for further insertion into the canal. The anteroposterior view will be used once the epidural needle is safely situated within the canal and the epidural catheter will be advanced cephalad. In this projection, the intermediate sacral crests will appear as opaque vertical lines on either side of the midline. The sacral foramina will be visualized as translucent and nearly circular areas lateral to the intermediate sacral crests. Once the correct placement of the needle will be confirmed, a catheter will be inserted into the desired location while depth and position will be confirmed fluoroscopically.
* Before the local anaesthetic will be injected, careful aspiration or passive drainage is essential to exclude an unintentional intravascular or intrathecal needle location. 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.
Group B: (general anaesthesia "control group")
-General anaesthesia will be induced as described above with administration of extra doses of fentanyl as needed according to hemodynamic changes suggesting pain sensation.
Post-operative setting:
* After completion of surgery, the residual neuromuscular block will be reversed with injection of neostigmine 0.05 mg/kg and atropine 0.01 mg/kg. When patients become suitable for extubation, with stable hemodynamic and adequate muscle power, thorough oral and endotracheal suction followed by extubation will be done.
* Patients will be nursed in post anaesthesia care unit for monitoring of post operative vital signs and for post operative pain assessment by numeric pain scale score at 0-hour and management accordingly.
* Patients postoperative pain will be followed up at the ward at time interval 0, 1, 2, 4, 6 hours.
* Patients will undergo close monitoring for the first 6 hours after caudal injection for overdose or adverse reactions.
* 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 1-10 as (0= no pain, 10 =worst imaginable pain) and hemodynamic parameters at 0, 1, 2, 4, 6 hours.
3. Time to rescue analgesia (intravenous analgesia administered after surgery) when the numeric pain scale score is 3 or higher. 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 in both groups.
6. Common complications of caudal block in the postoperative period which include hypotension, bradycardia, lower limb numbness and urinary retention. These complications will be recorded and managed accordingly.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group A: Patients doing lumbar fixation with combined continuous caudal epidural and general anaesthesia.
* Group B: Patients doing lumbar fixation under general anaesthesia (opioid analgesia).
OTHER
NONE
Study Groups
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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.
Combined continous caudal epidural with general anaesthesia
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.
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
Combined continous caudal epidural with general anaesthesia
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.
Interventions
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Combined continous caudal epidural with general anaesthesia
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.
Eligibility Criteria
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Inclusion Criteria
* Sex: Both sexes.
* American Society Association Classification (ASA): patients with ASA classification I, II.
* Elective lumbar fixation surgeries.
Exclusion Criteria
* Patients younger than 21 or older than 60.
* 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).
21 Years
60 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Esraa Abdellatif
Assistant lecturer of anesthesia, intensive care unit and pain management
Principal Investigators
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Omar Zafer, MD
Role: STUDY_DIRECTOR
Faculty of Medicine Ain Shams University
Paula Samaan, MD
Role: STUDY_DIRECTOR
Faculty of Medicine Ain Shams University
Ahmed El-Hennawy, MD
Role: STUDY_DIRECTOR
Faculty of Medicine Ain Shams University
Mahmoud Ghallab, MD
Role: STUDY_DIRECTOR
Faculty of Medicine Ain Shams University
Locations
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Faculty of Medicine , Ain Shams University
Cairo, Abbassia, Egypt
Countries
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References
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Hurley WR. Acute postoperative pain.In: Miller RD, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 7th ed. Philadelphia: Churchill Livingstone. 2010; 2757-81.
Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.
Schug SA, Bruce J. Risk stratification for the development of chronic postsurgical pain. Pain Rep. 2017 Oct 31;2(6):e627. doi: 10.1097/PR9.0000000000000627. eCollection 2017 Nov.
Waurick K, Waurick R. [History and Technique of Epidural Anaesthesia]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2015 Jul;50(7-8):476-82; quiz 483. doi: 10.1055/s-0041-100845. Epub 2015 Jul 31. German.
Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.
Abdel Hady Sarah Mahmoud Farid Mahmoud, Ahmed Azza Youssef Ibrahim, Neamat-Allah Hatem Saaed Abdel Hamid, et al. Combined caudal epidural with general anesthesia for lumbar discectomy. Ain Shams medical journal. 2022; 73(3): 695-704.
Al Oweidi AS, Klasen J, Al-Mustafa MM, Abu-Halaweh SA, Al-Zaben KR, Massad IM, Qudaisat IY. The impact of long-lasting preemptive epidural analgesia before total hip replacement on the hormonal stress response. A prospective, randomized, double-blind study. Middle East J Anaesthesiol. 2010 Jun;20(5):679-84.
Barham G, Hilton A. Caudal epidurals: the accuracy of blind needle placement and the value of a confirmatory epidurogram. Eur Spine J. 2010 Sep;19(9):1479-83. doi: 10.1007/s00586-010-1469-8. Epub 2010 May 29.
Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.
El-Feky EM and Abd El Aziz AA. Fentanyl, dexmedetomidine, dexamethasone as adjuvant to local anesthetics in caudal analgesia in pediatrics. Egypt J Anaesth. 2015; 31:175-80.
Ni Eochagain A, Singleton BN, Moorthy A, Buggy DJ. Regional and neuraxial anaesthesia techniques for spinal surgery: a scoping review. Br J Anaesth. 2022 Oct;129(4):598-611. doi: 10.1016/j.bja.2022.05.028. Epub 2022 Jul 9.
Fawzi HM, Almarakbi WA. Effect of a preemptive caudal dexmedetomidine-bupivacaine mixture in adult patients undergoing a single-level lumbar laminectomy. Ain Shams J Anesthesiol. 2012; 5:223-8.
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Kumar S, Palaniappan JM, Kishan A. Preemptive Caudal Ropivacaine: An Effective Analgesic during Degenerative Lumbar Spine Surgery. Asian Spine J. 2017 Feb;11(1):113-119. doi: 10.4184/asj.2017.11.1.113. Epub 2017 Feb 17.
Lakshminarasimhaiah G, Madabhushi R, Pai KR. Comparison of Epidural Anaesthesia and General Anaesthesia with Caudal Epidural Analgesia for Minimally Invasive Lumbosacral Spine Surgeries. Int J Anesth Pain Med. 2018; 4 :1-3.
Nagappa S, Kalappa S, Sridhara RB. Clonidine as an Adjuvant to Caudal Epidural Ropivacaine for Lumbosacral Spine Surgeries. Anesth Essays Res. 2018 Jan-Mar;12(1):240-245. doi: 10.4103/aer.AER_215_17.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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Continuous caudal epidural
Identifier Type: -
Identifier Source: org_study_id
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