Compartment Psoas Block Efficacy and Safety

Bogomolets National Medical University

Status: Completed

Conditions: Femur Fracture

Treatments: Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04648332

H35LP44qr9

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-proximal femur fracture

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride

Group 2

No Intervention group

Description:

Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine at a dose of 10-15 mg.

Group 3

No Intervention group

Description:

Group 3 patients underwent general inhalation anaesthesia with sevoflurane with a constant infusion of fentanyl for analgesia.