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CompletedNCT06929611Updated Apr 16, 2025

Analgesic Requirements for Lumbar Fixation With General Anaesthesia Versus Continuous Caudal Epidural

An interventional study of Combined continous caudal epidural with general anaesthesia in Analgesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Ain Shams University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

Read the 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:

  • 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.
02

Conditions studied

  • Analgesia
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Patients refuse to give informed consent.
  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Combined continous caudal epidural with general anaesthesia

  • Active comparator
    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

    Other: Combined continous caudal epidural with general anaesthesia

Interventions

  • OtherCombined 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.

06

What researchers measure

Primary outcomes

  1. Determining the total amount of fentanyl that will be consumed as intra operative analgesia

    the amount of fentanyl on micrograms used intra operative for both groups

    Time frame: during intraoperative period (from induction of anesthesia until recovery from general anaesthesia)

Secondary outcomes

  1. Determining the total amount of morphine that will be given as analgesia

    amount of morphine in mg

    Time frame: the first 6 hours post operative

  2. Analyzing the numeric pain scale score

    Post operative pain assessment according to numeric pain scale score 1-10 as (0= no pain, 10 =worst imaginable pain)

    Time frame: the first 6 hours post operative

  3. Detecting effect of continuous caudal epidural analgesia on intra operative and post operative on vital data (using heart rate)

    by detecting heart rate(beat/min.)

    Time frame: intra operative and the first 6 hours post operative

  4. Identifying the time to the first demand for rescue analgesia

    the time of first dose of morphine post operative

    Time frame: any time during the first 6 hours post operative

07

Study locations

1 site
  • Faculty of Medicine , Ain Shams University
    Cairo, Abbassia 11591, Egypt
08

References and documents

Publications

  • 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. PubMed 28337460 ↗
  • 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. PubMed 29392241 ↗
  • 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. PubMed 26230893 ↗
  • 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. PubMed 30857607 ↗
  • 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. PubMed 20803856 ↗
  • 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. PubMed 20512512 ↗
  • 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. PubMed 28913452 ↗
  • 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. PubMed 35817613 ↗
  • 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. PubMed 23392233 ↗
  • 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. PubMed 28243379 ↗
  • 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. PubMed 29628589 ↗

Study documents

  • Study protocol · Apr 9, 2025
  • Informed consent form · Apr 9, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — all data that underlie results in a publication

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06929611
Lead sponsor
Ain Shams University
Responsible party
Esraa Abdellatif (Assistant lecturer of anesthesia, intensive care unit and pain management, Ain Shams University) — Principal investigator
First posted
Apr 16, 2025
Start date
Jan 15, 2024
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Apr 16, 2025

Study contacts

Omar Zafer, MD
study director · Faculty of Medicine Ain Shams University
Paula Samaan, MD
study director · Faculty of Medicine Ain Shams University
Ahmed El-Hennawy, MD
study director · Faculty of Medicine Ain Shams University
Mahmoud Ghallab, MD
study director · Faculty of Medicine Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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