NCT06417203

Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty

Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Adiyaman University Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare the effects of hypobaric and hyperbaric spinal applications on patient haemodynamics, duration of anaesthetic effect and postoperative analgesia. Thus, it was aimed to determine the method that protects haemodynamics more and suppresses postoperative pain complaints of patients better in this patient group with advanced age, comorbid systemic diseases and high risk of operation.

Detailed description

Patients who are planned to be operated for partial hip replacement at Adıyaman University Training and Research Hospital, who are informed about the study and who agree to participate in the study with their written consent will be included in the study. Patients who agree to participate in the study will be divided into two groups: hypobaric and hyperbaric spinal anaesthesia patients will be divided into two groups to be decided by the Anaesthesiology and Reanimation specialist responsible for the operation (hyperbaric/hypobaric). Before the start of the operation, perfusion index (PI) values will be monitored with a probe in both lower extremities with standard ASA monitoring. Haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), PI values of both extremities, duration of motor and sensory block, postoperative numeric pain scores of all patients will be recorded and these values will be compared in both groups. Thus, it was aimed to compare the efficacy, safety, block times and contribution to pain management of each application.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	spinal anesthesia with hyberbaric bupivacaine	After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 10 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space. (modified from the initially registered 12.5 mg due to the higher incidence of hypotension and bradycardia observed with 12.5 mg in our institutional practice, prompting a safety-driven revision)
PROCEDURE	spinal anesthesia with hypobaric bupivacaine	After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 10 mg hypobaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space. (modified from the initially registered 12.5 mg due to the higher incidence of hypotension and bradycardia observed with 12.5 mg in our institutional practice, prompting a safety-driven revision)

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-08-31
• Completion: 2024-09-15
• First posted: 2024-05-16
• Last updated: 2025-12-10

Locations

1 site across 1 country: Turkey (Türkiye)