Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-09-15

Brief Summary

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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.

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Detailed Description

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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

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two gropus planned for study

1. group - Hyperbaric spinal anesthesia
2. group - Hypobaric spinal anesthesia

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

for patient - closed envelope system for Outcomes Assessor - will not participate perioperative period and will not know group of patients

Study Groups

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Hypobaric group

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

Group Type EXPERIMENTAL

spinal anesthesia with hypobaric bupivacaine

Intervention Type 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)

Hyberbaric group

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

Group Type EXPERIMENTAL

spinal anesthesia with hyberbaric bupivacaine

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* 18-65 aged

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No