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NCT Number: NCT03746418

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

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).

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Key information

Conditions

Double Level Lumbar Spondylolisthesis (L3-L5) Bone Diseases Lumbar Fixation Surgery Musculoskeletal Diseases Posterior Lumbar Interbody Fusion (PLIF) Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ahmed Said Elgebaly

Tanta, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • mohmed naser shaddad,MD
  • mona bologh elmorad,MD

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2018
Registry last updated
Nov 20, 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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