Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417203
• Other study ID #: 11.05.2024-ADYU-ANS-NY-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: May 2024
• Source: Adiyaman University Research Hospital
• Contact: Nezir Yilmaz
• Phone: 05068939496
• Email: yilmaznezirr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 15, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I-II

Exclusion Criteria:

• ASA III-IV

• Deny to participiate

• conditions that spinal anesthesia contraindicated

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• spinal anesthesia with hyberbaric bupivacaine
After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 12.5 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space.
• spinal anesthesia with hypobaric bupivacaine
After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 12.5 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space.

Locations

Country	Name	City	State
Turkey	Adiyaman Training and Research Hospital	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog pain score (VAS)	a tool that asses patinet paiin level 0 (no pain) -10 (the worst pain ever had) , the tool will be used at postopertaive period	three months
Secondary	Quality of recovery (QoR-15)	a tool that asses recovery quality of patient with 15 question will be used 24th hour after surgery	Three months