Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-27 @ 4:03 PM
Study NCT ID:
NCT04648332
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compartment Psoas Block Efficacy and Safety
Sponsor:
Bogomolets National Medical University
Organization:
Study Overview
Official Title:
Compartment Psoas Block Efficacy and Safety for Perioperative Analgesia in the Elderly With Proximal Femur Fractures: a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized controlled trial to assess the efficacy and safety of the prolonged compartment psoas block for analgesia and anesthesia for femur surgery in the elderly
Detailed Description:
A randomized controlled trial was conducted from January 2018 to August 2019 at the Into-Sana Medical Center (Odessa, Ukraine). The study design was approved by the Ethical Committee at Bogomolets National Medical University. Patients who planned osteosynthesis of the proximal femur and who met the inclusion criteria were randomized to 3 study groupsThe aim of our study was to compare the effectiveness and safety of different techniques of perioperative anaesthesia and anaesthesia in patients with fractures of the proximal femur: general anaesthesia and systemic analgesia, neuraxial (spinal) anaesthesia, compartment psoas block in combination with a sciatic nerve block. Patients in group 1 underwent catheterization of the lumbar plexus from the posterior access on admission to the hospital and began analgesia with bupivacaine 0.125% 6-8 ml / h. Intraoperative anesthesia was provided with a bupivacaine bolus of 0.5% 200 mg in a lumbar catheter and a sciatic nerve block with 1.5% 450 mg of lidocaine. Postoperative analgesia was provided with prolonged lumbar plexus block with bupivacaine 0.125% 6-8 ml / h.
Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine 10-15 mg. Patients in groups 1 - 2 receive intraoperative sedation with propofol 1% with a target level of sedation RASS from 0 to -2. Group 3 patients underwent general sevoflurane inhalation anaesthesia with fentanyl infusion for analgesia.
All patients received paracetamol 3g/day and dexketoprofen 75 mg/day during hospitalization. On-demand, nalbuphine 5 mg SC was used for analgesia.
Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine 10-15 mg. Patients in groups 1 - 2 receive intraoperative sedation with propofol 1% with a target level of sedation RASS from 0 to -2. Group 3 patients underwent general sevoflurane inhalation anaesthesia with fentanyl infusion for analgesia.
All patients received paracetamol 3g/day and dexketoprofen 75 mg/day during hospitalization. On-demand, nalbuphine 5 mg SC was used for analgesia.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: