Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty

Not Applicable

Recruiting

• Conditions: Post Operative Pain
• Interventions: Procedure: spinal anesthesia with hypobaric bupivacaine; Procedure: spinal anesthesia with hyberbaric bupivacaine

• Registration Number: NCT06417203
• Lead Sponsor: Adiyaman University Research Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-11
• Study First Posted: 2024-05-16
• Study Start: 2024-06-01
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA I-II

Exclusion Criteria

• ASA III-IV
• Deny to participiate
• conditions that spinal anesthesia contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypobaric group	spinal anesthesia with hypobaric bupivacaine	In this group, hypobaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery
Hyberbaric group	spinal anesthesia with hyberbaric bupivacaine	In this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery

Primary Outcome Measures

Name	Time	Method
Visual analog pain score (VAS)	three months	a tool that asses patinet paiin level 0 (no pain) -10 (the worst pain ever had) , the tool will be used at postopertaive period

Secondary Outcome Measures

Name	Time	Method
Quality of recovery (QoR-15)	Three months	a tool that asses recovery quality of patient with 15 question will be used 24th hour after surgery

Trial Locations

Locations (1)

Adıyaman Training and Research Hospital; 🇹🇷 Adıyaman, Turkey