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Completed

NCT Number: NCT04648332

Compartment Psoas Block Efficacy and Safety

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bogomolets NMU

Kyiv, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bupivacaine Hydrochloride

Drug

compartment psoas block

Other names: regional anesthesia, compartment psoas block

Primary outcomes

  1. postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay

    Time frame: 72 hours

    postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay

Secondary outcomes

  1. ICU length of stay and the total duration of hospitalization

    Time frame: 102 hours

    ICU length of stay and the total duration of hospitalization

  2. number of patients who had severe pain after surgery

    Time frame: 72 hours

    number of patients who had severe pain after surgery

  3. incidence of on-demand analgesia

    Time frame: 72 hours

    incidence of on-demand analgesia

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Registry information

Official study title

Compartment Psoas Block Efficacy and Safety for Perioperative Analgesia in the Elderly With Proximal Femur Fractures: a Randomized Controlled Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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