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

Tanta University

Status and phase: Completed; Early Phase 1

Conditions: Posterior Lumbar Interbody Fusion (PLIF); Lumbar Fixation Surgery; Double Level Lumbar Spondylolisthesis (L3-L5)

Treatments: Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03746418

tantaESB

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Group I

Placebo Comparator group

Description:

received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.

Treatment:

Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block

Group II

Active Comparator group

Description:

received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally

Treatment:

Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block