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

NCT06929611 | Completed DMC

• 1 other identifier: Continuous caudal epidural
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

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

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

Secondary Outcomes (4)

• 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

Study Arms (2)

Combined continuous caudal epidural and general anaesthesia

ACTIVE COMPARATOR

-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

General anaesthesia (opioid analgesia)

ACTIVE COMPARATOR

-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

Combined continous caudal epidural with general anaesthesia OTHER

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.

Combined continuous caudal epidural and general anaesthesia; General anaesthesia (opioid analgesia)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine , Ain Shams University

Cairo, Abbassia, 11591, Egypt

Location

Related Publications (16)

• 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.

  BACKGROUND

• 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.

  PMID: 28337460 BACKGROUND

• 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.

  PMID: 29392241 BACKGROUND

• 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.

  PMID: 26230893 BACKGROUND

• 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.

  PMID: 30857607 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 20803856 RESULT

• 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.

  PMID: 20512512 RESULT

• 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.

  PMID: 28913452 RESULT

• 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.

  RESULT

• 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.

  PMID: 35817613 RESULT

• 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.

  RESULT

• 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.

  PMID: 23392233 RESULT

• 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.

  PMID: 28243379 RESULT

• 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.

  RESULT

• 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.

  PMID: 29628589 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Omar Zafer, MD

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Paula Samaan, MD

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Ahmed El-Hennawy, MD

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Mahmoud Ghallab, MD

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia, intensive care unit and pain management

Model Details: Patients will be randomly allocated by computer generated randomization into two equal groups A and B. * 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).

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: April 16, 2025
• Study Start: January 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: the data will be available at the end of the study nearly in six months It will be available once the paper of the study is published in a journal
• Access Criteria: the data will be shared with any researcher interested in subject

Locations

EG (1)