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
- Conditions
- Posterior Lumbar Interbody Fusion (PLIF)Double Level Lumbar Spondylolisthesis (L3-L5)Lumbar Fixation Surgery
- Interventions
- Drug: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
- Registration Number
- NCT03746418
- Lead Sponsor
- 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).
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I Ultrasound Guided Bilateral single shot Erector Spinae Plane Block received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally. Group II Ultrasound Guided Bilateral single shot Erector Spinae Plane Block received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally
- Primary Outcome Measures
Name Time Method changes in Post-Anesthesia Care Unit (PACU) length of stay 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.
changes in the total dose of postoperative analgesics need 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.
changes in recovery time 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.
changes in postoperative visual analogue score (VAS) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ahmed Said Elgebaly
🇪🇬Tanta, Egypt