Pain, Postoperative Clinical Trial
Official title:
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study
Verified date | April 2021 |
Source | Bozyaka Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL). One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL. The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 15, 2019 |
Est. primary completion date | March 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia - Patients who has informed consent for study - Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II Exclusion Criteria: - Patient's refusal to participate - Patients under 18 years of age - Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.) - Patients with known local anesthetic allergy - Patients with Body mass index > 35 - Patients diagnosed sepsis and bacteriemia, - Skin infection at the injection site, - Patients with previous spinal surgery - History of coagulopathy or anticoagulant therapy - Patients with uncontrolled diabetes , - Uncoordinated patients, - Psychological and emotional lability, - Surgical intervention longer than 3 hours. |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Bozyaka Training and Research Hospital | Karabaglar | Izmir |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dosage of Drugs | Amounts of drugs per kilogram per hour will be recorded | During procedure | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 30th minute postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 60th minute postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 2nd hour postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 6th hour postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 12th hour postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 24th hour postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 48th hour postoperatively | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded during the first steps as reported by the patient according to NRS | Mobilisation at postoperative day (POD) 1 | |
Primary | Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded during the procedure as reported by the patient according to NRS | At the time of removal of nephrostomy at postoperative day (POD) 2 | |
Secondary | Opioid Consumption | Opioids(Tramadol) will be administered to patients in case demanded. | 48 hour post-operatively | |
Secondary | Discharge | Day of the discharge | 240 hours post-operatively |
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