faculty of medicine, Alexandria Unverisity
Alexandria, 21521, Egypt
NCT Number: NCT06246292
The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). This technique can be guided by ultrasound or anatomical landmarks, and it can be performed while the patient is lying down, sitting or on their side.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Alexandria, 21521, Egypt
Ultrasound guidance has established itself as the norm for regional anesthesia procedures, enabling live visualization of anatomical structures and enhancing the precision and safety of needle insertion. Conversely, the blind technique relies on anatomical landmarks and the ability to palpate to direct needle insertion. Although the blind technique might provide simplicity and efficiency, uncertainties persist concerning its precision and possible associated risks. As the popularity of the ESPB increases, a relevant query emerges: Should it be conducted with ultrasound guidance or through a non-guided technique? This study was designed to validate the efficacy and safety of a landmark-guided ESPB technique compared to an ultrasound-guided ESPB technique for analgesia in breast surgery. The hypothesis was that the ultrasound and anatomical landmark techniques for ESPB would provide equivalent analgesia. The study's primary objective was to compare the success rate of both techniques. The secondary objectives were to compare the dermatomal block spread, analgesic effectiveness, and technique-related complications.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ESPB is a truncal block guided by ultrasound, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra.
The ESPB is a truncal block guided by anatomical landmarks, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra.
Time frame: 30 minutes after regional block procedure
The primary outcome was the binary outcome: therapeutic success or failure of ESPB techniques in achieving cutaneous sensory block for breast surgery (from T1 to T6).
Time frame: 30 minutes after regional block procedure.
Assessment of the number of blocked cutaneous sensory dermatomes from T1 to T10.
Time frame: The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.
Assessment of rest visual analog score (VAS) for surgical site pain (0 -10) 2.
Time frame: During the regional block procedure.
Assessment of occurrence of adverse effects.
Time frame: The first 24 hours postoperatively.
The time (minutes) to the first intravenous patient-controlled analgesia (IV-PCA) demand dose.
Time frame: intra- and 24 hours postoperatively
Total fentanyl opioid consumption (microgram).
Alexandria University
Other
Erector Spinae Plane Block: Anatomical Landmark Versus Ultra-sounded Guided Technique, a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07249827
Acute Pain, Agnosia
Montreal, Quebec, Canada
View Trial DetailsNCT06709625
Agnosia, Anesthesia and Analgesia
Ankara, Çankaya, Turkey (Türkiye)
View Trial DetailsNCT05034601
Agnosia, Analgesia
Chengdu, Sichuan, China
View Trial DetailsNCT05528627
Agnosia, Analgesia
Antalya, Turkey (Türkiye)
View Trial Details