Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577064
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Sacral Erector Spinae Block for Pilonidal Sinus Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sacral Erector Spinae Block for Pilonidal Sinus Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of pilonidal sinus disease PD is estimated to be around 26100000 individuals mostly menPD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidityDifferent surgical technique approaches were proposed for treatment with different rates of success
Detailed Description:
Sacral erector spinae plane block was first described by Tulgar et al To provide sensory blockade in the parasacral region in two cases who had pilonidal sinus surgeries Since then the block was used for multiple surgeries like anorecatal hip surgery and parasacral reconstructive surgeriesAfter obtaining the ethical committee approval from Menoufia University patients scheduled for pilonidal sinus surgery will be randomly allocated into one of two groups Patients will be randomized to a study group using a computer-generated random number table and the allocation concealment will be performed using a sealed envelope techniqueThe sealed opaque envelopes will be kept locked in dedicated research safe and will be accessed by a research coordinator only when a patient consented for the study The anesthetist will perform the intervention with the doses and concentration of drugs as per the protocol
The patients and the follow up researcher will be blinded to the type of intervention used The patient follow-up time will be scheduled intraoperatively PACU 1 hour and 24hours postoperatively The anesthetist who did the intervention will have no access to the reported documents or contact with the patient postoperatively
For induction of anesthesia all patients will receive medication as per the facility protocol where propofol 1-2mgKg fentanyl 2μgKg actual BW rocuronium 05 mgkg will be used for induction and an endotracheal tube intubation will be inserted to secure the airway After intubation and confirmation of endotracheal tube placement by auscultation and capnography the patient will be turned into prone position
Maintenance of anesthesia will be maintained by sevoflurane 1-12 MAC and rocuronium 01mgkg guided by the TOF All patients will receive multimodal analgesia in the form of paracetamol 1gm and parecoxib 40 mg Pizer manufacturing Belgium After exclusion of other causes of tachycardia and hypertension Morphine 2mg increments will be administrated to keep the heart rate or blood pressure within 20 percent of the patients baseline parameters
The patients and the follow up researcher will be blinded to the type of intervention used The patient follow-up time will be scheduled intraoperatively PACU 1 hour and 24hours postoperatively The anesthetist who did the intervention will have no access to the reported documents or contact with the patient postoperatively
For induction of anesthesia all patients will receive medication as per the facility protocol where propofol 1-2mgKg fentanyl 2μgKg actual BW rocuronium 05 mgkg will be used for induction and an endotracheal tube intubation will be inserted to secure the airway After intubation and confirmation of endotracheal tube placement by auscultation and capnography the patient will be turned into prone position
Maintenance of anesthesia will be maintained by sevoflurane 1-12 MAC and rocuronium 01mgkg guided by the TOF All patients will receive multimodal analgesia in the form of paracetamol 1gm and parecoxib 40 mg Pizer manufacturing Belgium After exclusion of other causes of tachycardia and hypertension Morphine 2mg increments will be administrated to keep the heart rate or blood pressure within 20 percent of the patients baseline parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None