An interventional study of C2-C4 compartment anesthetic block and Costagliola block in Somatic Pain and Neuropathic Pain, sponsored by San Salvatore Hospital of L'Aquila. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by San Salvatore Hospital of L'Aquila · Not applicable, Interventional, and Other
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C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy
A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block group of the C2-C4 compartment ) and the control group B (block group according to Costagliola), during the 3 months after surgery.
96 studies on the registry are indexed under Nociceptive Pain; 18 are open to participants now.
This study's enrollment of 100 is above the median of 61 across 62 interventional studies indexed under Nociceptive Pain.
Browse Nociceptive Pain studies →San Salvatore Hospital of L'Aquila is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: the C2-C4 compartment anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenous muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.
Procedure: C2-C4 compartment anesthetic block
Active Comparator: the Costagliola anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL injected in the posterior margin of the sternocleidomastoid muscle and along the anterior border of the same muscle.
Procedure: Costagliola block
C2-C4 compartment anesthetic block is performed by injecting levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenus muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.
Also known as: Intermediate cervical plexus block
Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle
Also known as: Superficial cervical plexus block
somatic pain
Somatic pain assessed by Numeric Pain Rating Scale for pain (the 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable"
Time frame: 3 mounths after surgery
Opiates request
Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery
Time frame: 3 mounths after surgery
Pregabalin request
Pregabalin request in mg, 3 months after surgery
Time frame: 3 months
Neuropathic pain
Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Nov 2018, 8 months.
Of 37 non-industry interventional studies with no phase under Nociceptive Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's 8 months is close to that.
Counting every sponsor, half of 42 studies reached it within 8 months; a quarter within 3 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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San Salvatore Hospital of L'Aquila