Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty

NCT06417203 | Completed

• 1 other identifier: 11.05.2024-ADYU-ANS-NY-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

  First postoperative 24 hours (The originally registered follow-up period of 3 months was entered in error. The intended and actual outcome assessment period for this study is the first 24 postoperative hours.)

Secondary Outcomes (1)

• Quality of recovery (QoR-15)

  first postoperative24 hours(The originally registered follow-up period of 3 months was entered in error. The intended and actual outcome assessment period for this study is the first 24 postoperative hours, as correctly stated in the description section)

Study Arms (2)

Hyberbaric group

EXPERIMENTAL

In this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery

Procedure: spinal anesthesia with hyberbaric bupivacaine

Hypobaric group

EXPERIMENTAL

In this group, hypobaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery

Procedure: spinal anesthesia with hypobaric bupivacaine

Interventions

spinal anesthesia with hyberbaric bupivacaine PROCEDURE

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)

Hyberbaric group

spinal anesthesia with hypobaric bupivacaine PROCEDURE

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)

Hypobaric group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• aged

You may not qualify if:

• ASA III-IV
• Deny to participiate
• conditions that spinal anesthesia contraindicated
• use of alpha or beta-blockers
• allergy to local anesthetics
• diabetes mellitus

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adıyaman Training and Research Hospital

Adıyaman, 02200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: for patient - closed envelope system for Outcomes Assessor - will not participate perioperative period and will not know group of patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor,MD

Model Details: two gropus planned for study 1. group - Hyperbaric spinal anesthesia 2. group - Hypobaric spinal anesthesia

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 15, 2024
• Last Updated: December 10, 2025

Record last verified: 2024-05

Locations

TU (1)