Compartment Psoas Block Efficacy and Safety
- Registration Number
- NCT04648332
- Lead Sponsor
- Bogomolets National Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
-proximal femur fracture
- pregnancy and lactation
- history of opiate addiction
- traumatic brain injury
- acute cerebrovascular accident
- chronic heart failure (New York Heart Association Functional Classification, NYHA, class III-IV)
- respiratory failure
- renal failure with decreased creatinine clearance less than 30 ml / min / 1.73 m2
- hepatic insufficiency class C according to Child-Pugh).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Bupivacaine Hydrochloride 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 anaesthesia 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 by an elongated lumbar plexus block with bupivacaine 0.125% 6-8 ml / h.
- Primary Outcome Measures
Name Time Method postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay 72 hours postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay
- Secondary Outcome Measures
Name Time Method number of patients who had severe pain after surgery 72 hours number of patients who had severe pain after surgery
incidence of on-demand analgesia 72 hours incidence of on-demand analgesia
ICU length of stay and the total duration of hospitalization 102 hours ICU length of stay and the total duration of hospitalization
Trial Locations
- Locations (1)
Bogomolets NMU
🇺🇦Kyiv, Ukraine