Post Operative Pain
Conditions
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.
Interventions
PROCEDUREspinal 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)
PROCEDUREspinal 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)
Sponsors
Adiyaman University Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
for patient - closed envelope system for Outcomes Assessor - will not participate perioperative period and will not know group of patients
Intervention model description
two gropus planned for study 1. group - Hyperbaric spinal anesthesia 2. group - Hypobaric spinal anesthesia
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * peripheral vascular disease (The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog pain score (VAS) | 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.) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | a tool that asses recovery quality of patient with 15 question will be used 24th hour after surgery |
Countries
Turkey (Türkiye)
Outcome results
None listed