EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON TOTAL HIP ARTHROPLASTY
1 other identifier
interventional
50
1 country
1
Brief Summary
Total hip arthroplasty (THA) is a surgery that relieves hip joint pain and improves its functions and is widely performed in the elderly population. New analgesic methods need to be developed to protect these patients from the pain and side effects of opioids used for treatment. Many scales are available to indicate postoperative patient recovery. One of these is the quality of recovery-15 (QoR-15) recovery test, which was first applied by Stark et al. in 2013. We think that an ESPB applied from the sacral region will spread to the lumbar region by diffusion, affect the lumbar plexus, and provide complete analgesia in the ventral and dorsal regions of the hip by affecting the sacral plexus in the sacral region. The investigator's primary aim in this study is to evaluate the effect of sacral erector spinae plane block (S-ESPB) on the quality of recovery and healing after TKA through the QoR-15 score and to evaluate its effect on postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Jan 2024
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 24, 2024
CompletedStudy Start
First participant enrolled
January 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedApril 16, 2024
April 1, 2024
3 months
December 11, 2023
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of recovery-15T
The primary evaluation criteria will be the recording of QoR -15 scores, which indicate the quality of recovery of patients before and at 24 hours after surgery .
One day
Study Arms (2)
control group
NO INTERVENTIONGroup K IV to patients paracetamol 1 gr. It will be administered 3x1 + Dexketoprofen 50 mg 2x1. All patients will be administered 1mg/kg tramadol as rescue analgesic when NRS is 3 and above . 4mg IV to all patients with nausea and vomiting Ondansetron will be administered.
Sacral erektör spinae plane group
ACTIVE COMPARATORsacral erector spinae plane will be applied to patients in Group S
Interventions
sacral erectör spinae plane will be applied to patients in Group S
Eligibility Criteria
You may qualify if:
- Patients who will undergo unilateral THA
- Spinal anesthesia
- year-old patients
- Patients with ASA I-IV
- Patients who will stay in the hospital for at least 24 hours
You may not qualify if:
- Patients who do not want to give consent
- Patients under 18 years of age and over 80 years of age
- Patients for whom regional anesthesia is contraindicated
- Patients with confusion
- Patients with ASA V and above
- Patients with abnormal bleeding profile
- Patients using anticoagulants
- Patients with infection in the area to be treated
- Emergency cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konya City Hospital
Konya, 42020, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist, the member of the Department of Anesthesiology, Konya City Hospital, M.D
Study Record Dates
First Submitted
December 11, 2023
First Posted
January 24, 2024
Study Start
January 24, 2024
Primary Completion
April 15, 2024
Study Completion
April 15, 2024
Last Updated
April 16, 2024
Record last verified: 2024-04