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NCT Number: NCT03438240

Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.

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Key information

Conditions

Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University hospitals

Cairo, 11591, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physical status American Society of Anesthesiologist (ASA) I or II.
  • First time elective lumbar dicsectomy or laminectomy

Exclusion criteria

  • Patients who refuse to participate
  • Body mass index (BMI) > 30
  • Need an emergency lumbar disc operation
  • ASA physical status > II
  • Major illnesses (e.g. cardiac, respiratory, renal, liver)
  • Coagulation abnormalities
  • Hypovolemia
  • History of increased intracranial pressure
  • Convulsions
  • Spinal stenosis
  • Infection at needle insertion site
  • Other contraindications to epidural procedure
  • Allergy or contraindications to the drugs used in the study
  • History of addiction or alcohol abuse
  • Psychiatric illness or mental retardation

Treatment and study plan

Bupivacaine

Drug

patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%

Other names: Local anesthetic

Fentanyl

Drug

Plus 50 µg fentanyl

Other names: Opioid

Dexmedetomidine

Drug

Plus 50 µg dexmedetomidine

Other names: alpha 2 sympathomimetic

Primary outcomes

  1. First time to analgesic requirement

    Time frame: First 24 hours postoperatively

    After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.

Secondary outcomes

  1. Total opioid consumption

    Time frame: First 24 hours postoperatively

    Total morphine consumption per twenty four hours will be estimated

  2. Visual analogue scale (VAS)

    Time frame: First 24 hours postoperatively

    Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Adding Dexmedetomidine Versus Fentanyl to Bupivacaine for Epidural Analgesia in Combination With General Anesthesia for Elective Lumbar Disc Operations: Prospective, Randomized Double-blinded Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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