Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery

Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine surgeries should be implemented to prevent CNS plasticity and to provide effective pain relief.

The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief.

The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine, dexmedetomidine), or their combination. This study will compare adding different non opioid adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine surgery which can be a part of multimodal analgesia protocol.

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Study Overview

• Status: Completed
• Conditions: Caudal Analgesia for Lumosacral Spine Surgeries
• Intervention / Treatment: Drug: Bupivacaine; Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: Hyalouridinase

Detailed Description

60 patient will be enrolled in the study. They will be allocated randomly into 3 groups. after induction of general anesthesia and changing the patient into prone position injection of the study cocktail through caudal epidural route.(20 ml before skin incision and 10 ml of the same mixture at the end of surgery) in all patients.

In the first group patients will receive 0.125% bupivacaine with 8 mg dexamethasone In the second group we will add 50µg dexmedetomidine to the previous mixture given to the first group.

In the third group we will add 1500 IU hyalurodinase to the mixture given to the first group

During the operation adjustment of sevoflurane concentration and fentanyl incremental doses (0.5 μg/kg) will be according to hemodynamic measurements.

Clinical signs of inadequate analgesia is defined as an increase in blood pressure and heart rate more than 20% from baseline. Efficacy of the caudal epidural block will be tested at beginning of skin incision (15-20 minutes after block). If signs of inadequate analgesia are observed, fentanyl 0.5 µg/kg will be given and those patients will be excluded from the study.

In case of decrease in Blood Pressure greater than 20% from baseline, the patient will be infused by 500 ml ringer lactate and if blood pressure is not responding, administration of increments of 3 mg ephedrine will be given. Also If heart rate decreased to 45 beats/min, atropine sulfate 0.01 mg/kg will be given. Muscle paralysis will be antagonized by sugmmadex 2mg/kg at the end of surgery after switching the patient to the supine position.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ainshams hospitals
  • New Cairo
    • Cairo, New Cairo, Egypt, 11835
      • Sanaa Farag Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients are aged from 18-65 years , ASA I and II, scheduled for lumbar spine surgery (laminectomy, discectomy, foraminotomy, fenestration or fusion) in a virgin back.

Exclusion Criteria:

• Patients with multiple level fixation, revision surgery, complicated spinal canal stenosis, traumatic lumbar surgeries were excluded, patients with addiction, allergy to local anesthetics or to any drug used in the study and those with coagulation abnormality are also excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; patients will receive 30 ml of 0.125% bupivacaine with 8 mg dexamethasone (20 ml before skin incision and 10 ml at end of surgery	Drug: Bupivacaine; local anesthetics, steriod, alpha 2 blockers; Drug: Dexamethasone; dexamethazone
Active Comparator: group B; we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery	Drug: Bupivacaine; local anesthetics, steriod, alpha 2 blockers; Drug: Dexamethasone; dexamethazone; Drug: Dexmedetomidine; dexmedetomidine
Active Comparator: group c; we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery	Drug: Bupivacaine; local anesthetics, steriod, alpha 2 blockers; Drug: Dexamethasone; dexamethazone; Drug: Hyalouridinase; hyalouridinase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of analgesia	time from second dose caudal epidural block to first analgesic requirement	postoerative 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	VAS score from zero for (no pain) till 10 for ( the most severe intractable pain)	postoperative 24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• Solanki SL, Bharti N, Batra YK, Jain A, Kumar P, Nikhar SA. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care. 2013 Jan;41(1):51-6. doi: 10.1177/0310057X1304100110.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexamethasone; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: R15/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No