Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Double Level Lumbar Spondylolisthesis (L3-L5)
Posterior Lumbar Interbody Fusion (PLIF)
Lumbar Fixation Surgery
Keywords: erector spinae
dexmedetomidine
ultrasound
lumbar interbody fusion
spondylolisthesis
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: mona bologh elmorad,MD
name: mohmed naser shaddad,MD
First posted: 2018-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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).

Eligibility 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.

Primary outcomes:
measure: changes in Post-Anesthesia Care Unit (PACU) length of stay
timeFrame: at 1hours, 6hours, 12hours, and 24 hours after the operation
measure: changes in the total dose of postoperative analgesics need
timeFrame: at 1hours, 6hours, 12hours, and 24 hours after the operation
measure: changes in postoperative visual analogue score (VAS)
timeFrame: at 1hours, 6hours, 12hours, and 24 hours after the operation
measure: changes in recovery time
timeFrame: at 1hours, 6hours, 12hours, and 24 hours after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ahmed Said Elgebaly
Study officials:
References:
citation: Chaudhary NK, Singh S. Continuous ultrasound-guidederector spinae plane block for post-operative pain management in lumbar spine surgery: A case series. Indian J Anaesth. 2018 Aug;62(8):638-639. doi: 10.4103/ija.IJA_160_18. No abstract available.
citation: Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.
citation: Zhang S, Ye C, Lai Q, Yu X, Liu X, Nie T, Zhan H, Dai M, Zhang B. Double-level lumbar spondylolysis and spondylolisthesis: A retrospective study. J Orthop Surg Res. 2018 Mar 16;13(1):55. doi: 10.1186/s13018-018-0723-3.
citation: Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.