An Early Phase 1 interventional study of Ultrasound Guided Bilateral single shot Erector Spinae Plane Block in Double Level Lumbar Spondylolisthesis (L3-L5), Posterior Lumbar Interbody Fusion (PLIF) and Lumbar Fixation Surgery, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Tanta University · Early Phase 1, Interventional, and Prevention
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).
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).
237 studies on the registry are indexed under Spondylolisthesis; 47 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 149 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.
Drug: 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
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.
changes in Post-Anesthesia Care Unit (PACU) length of stay
assessment of changes in the Post-Anesthesia Care Unit (PACU) length of stay in (minutes) during the first 24 hours was reported.
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
changes in the total dose of postoperative analgesics need
assessment of changes in the total dose of postoperative analgesics need in the first 24 hours were reported.
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
changes in postoperative visual analogue score (VAS)
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.
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
changes in recovery time
assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.
Time frame: at 1hours, 6hours, 12hours, and 24 hours after the operation
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