Cairo University
Cairo, 12613, Egypt
Location status: Recruiting
Location contact
Ahmed Mansour, MD
PRINCIPAL_INVESTIGATOR
Mohamed E Abdel Fattah, MD
CONTACT
Mohammed S ElSharkawy, MD
PRINCIPAL_INVESTIGATOR
Samuel F Samy, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06974643
This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
Ahmed Mansour, MD
PRINCIPAL_INVESTIGATOR
Mohamed E Abdel Fattah, MD
CONTACT
Mohammed S ElSharkawy, MD
PRINCIPAL_INVESTIGATOR
Samuel F Samy, MD
PRINCIPAL_INVESTIGATOR
Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery.
Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will preoperatively receive an awake thoracic epidural block.
Patients will preoperatively receive a paravertebral block.
Time frame: Intraoperatively
Additional bolus doses of fentanyl 0.5µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Time frame: 48 hours postoperatively
Time to first request of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.
Time frame: Till the end of surgery (Up to 2 hours)
Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery
Time frame: Till the end of surgery (Up to 2 hours)
Heart rate will be recorded at baseline, and every 15min till the end of surgery
Time frame: 48 hours postoperatively
If numeric rating scale (NRS)>3 at rest will be observed, rescue analgesia via IV morphine 3 mg boluses will be administered.
Time frame: 48 hours postoperatively
The patients will be instructed how to report pain by the numeric rating scale (NRS) [on a scale from (0 to 10), zero means no pain and ten means the worst pain]. NRS will be measured at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, 18, 24, 36, 48 hours postoperatively at rest and movement
Time frame: 48 hours postoperatively
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Time frame: 48 hours postoperatively
Incidence of adverse events such as nausea, vomiting, respiratory depression, hypotension and bradycardia
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
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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.
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