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Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia

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ClinicalTrials.gov Identifier: NCT03746418
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
mona bologh elmorad,MD
mohmed naser shaddad,MD
Information provided by (Responsible Party):
Ahmed Said Elgebaly,MD, Tanta University

Brief Summary:
Posterior lumbar interbody fusion (PLIF) is the management of choice in double level lumbar (L) spondylolisthesis (L3-L5) after ineffective conservative treatment. We evaluated bilateral ultrasound (US)-guided single shot erector spinae plane (ESP) block at the level of lumbar 3 (L3) vertebra with or without dexmedetomidine (Dex).

Condition or disease Intervention/treatment Phase
Double Level Lumbar Spondylolisthesis (L3-L5) Posterior Lumbar Interbody Fusion (PLIF) Lumbar Fixation Surgery Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block Early Phase 1

Detailed Description:

Objectives: Posterior lumbar interbody fusion (PLIF) is the management of choice in double level lumbar (L) spondylolisthesis (L3-L5) after ineffective conservative treatment. We evaluated bilateral ultrasound (US)-guided single shot erector spinae plane (ESP) block at the level of lumbar 3 (L3) vertebra with or without dexmedetomidine (Dex).

Methods: A prospective controlled randomized, double-blind study comparing two groups of patients; each group included 20 patients of double level spondylolisthesis (L3-L5) scheduled for (PLIF) under general anesthesia combined with bilateral US-guided ESP single shot block at (L3). Group I received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally. Group II received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally. Post-Anesthesia Care Unit (PACU) length of stay, the total dose of postoperative analgesics need, postoperative visual analogue score (VAS) at 1h, 6h, 12h, and 24 h after the operation and postoperative complications which related to block or opioids were recorded.

ESP block at combined with (Dex) is a safe, effective block with no complications. Addition of 100µg Dex to preoperative ESP block provided good postoperative opioid-sparing analgesia, facilitated the early emergence and shortened the length of stay in the PACU during (PLIF) for double level spondylolisthesis (L3-L5).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Placebo Comparator: Group I
received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.
Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Under aseptic technique and after skin infiltration with 3 ml of 2% lidocaine, a 22G, 50-mm, insulated facet type needle (visioplex® - vygon - France) was introduced in plane in a cephalad to caudad direction until (L3) transverse process was hit [figure1(A)(B)(C)] and the needle was slightly withdrawn. The confirmation of the correct position of the needle tip was done by injecting 0.5-1 ml of LA. Once confirmed, 20 ml of the drug was administered under vision after confirming negative aspiration of blood. LA distribution was observed in both cranial and caudal directions. This was repeated on the other side also. Twenty minutes later, sensory loss to cold was evident between (T10-T 12) and (L5-S1) vertebral level of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) on both sides without hemodynamic changes. Motor function of the legs was evaluated with a Bromage (0-3) score.

Active Comparator: Group II
received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally
Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Under aseptic technique and after skin infiltration with 3 ml of 2% lidocaine, a 22G, 50-mm, insulated facet type needle (visioplex® - vygon - France) was introduced in plane in a cephalad to caudad direction until (L3) transverse process was hit [figure1(A)(B)(C)] and the needle was slightly withdrawn. The confirmation of the correct position of the needle tip was done by injecting 0.5-1 ml of LA. Once confirmed, 20 ml of the drug was administered under vision after confirming negative aspiration of blood. LA distribution was observed in both cranial and caudal directions. This was repeated on the other side also. Twenty minutes later, sensory loss to cold was evident between (T10-T 12) and (L5-S1) vertebral level of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) on both sides without hemodynamic changes. Motor function of the legs was evaluated with a Bromage (0-3) score.




Primary Outcome Measures :
  1. changes in Post-Anesthesia Care Unit (PACU) length of stay [ Time Frame: at 1hours, 6hours, 12hours, and 24 hours after the operation ]
    assessment of changes in the Post-Anesthesia Care Unit (PACU) length of stay in (minutes) during the first 24 hours was reported.

  2. changes in the total dose of postoperative analgesics need [ Time Frame: at 1hours, 6hours, 12hours, and 24 hours after the operation ]
    assessment of changes in the total dose of postoperative analgesics need in the first 24 hours were reported.

  3. changes in postoperative visual analogue score (VAS) [ Time Frame: at 1hours, 6hours, 12hours, and 24 hours after the operation ]

    assessment of changes in the postoperative visual analogue score (VAS)in the first 24 hours was reported.

    Scoring and Interpretation: Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) . Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.


  4. changes in recovery time [ Time Frame: at 1hours, 6hours, 12hours, and 24 hours after the operation ]
    assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • belonged to the American Society of Anesthesiologists (ASA) physical status I or II
  • either sex
  • aged 18-60 years
  • body mass index less 35 kg/m2
  • complaining from double level lumbar spondylolisthesis (L3-L5)
  • scheduled for elective surgical intervention aimed at lumbar spine fixation by PLIF - under general anesthesia.

Exclusion Criteria:

  • obesity (body mass index > 35 kg/m2)
  • infection of the skin at the site of the needle puncture
  • allergies to either of the study drugs
  • bleeding disorder
  • and recent use of opioid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746418


Locations
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Egypt
Ahmed Said Elgebaly
Tanta, Egypt
Sponsors and Collaborators
Tanta University
mona bologh elmorad,MD
mohmed naser shaddad,MD

Publications of Results:
Other Publications:
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Responsible Party: Ahmed Said Elgebaly,MD, director, Tanta University
ClinicalTrials.gov Identifier: NCT03746418     History of Changes
Other Study ID Numbers: tantaESB
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ahmed Said Elgebaly,MD, Tanta University:
erector spinae
dexmedetomidine
ultrasound
lumbar interbody fusion
spondylolisthesis
Additional relevant MeSH terms:
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Spondylolisthesis
Hypnotics and Sedatives
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action