Post Operative PainNCT06417203
Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty
A study testing spinal anesthesia with hyberbaric bupivacaine and spinal anesthesia with hypobaric bupivacaine in people with Post Operative Pain, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- spinal anesthesia with hyberbaric bupivacaine and spinal anesthesia with hypobaric bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- 18-65 aged
Who cannot join
- 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 exclusion criteria were added to ensure patient safety and to avoid confounding factors that could interfere with perfusion index measurements or hemodynamic responses: use of alpha or beta-blockers, diabetes mellitus, and peripheral vascular disease. These conditions may significantly alter autonomic regulation, vascular tone, or peripheral circulation, potentially affecting perfusion index values or increasing the risk of adverse reactions to spinal anesthesia)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman Training and Research Hospital
Adıyaman, 02200
About this study
Official title: Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index?
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.
Read the 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.
- Conditions
- Post Operative Pain
- Being tested
- spinal anesthesia with hyberbaric bupivacaine, spinal anesthesia with hypobaric bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia with hyberbaric bupivacaineProcedure or surgery
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)
spinal anesthesia with hypobaric bupivacaineProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Hyberbaric group | Experimental | In this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery Receives: 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 Receives: Procedure: spinal anesthesia with hypobaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
a tool that asses recovery quality of patient with 15 question will be used 24th hour after surgery
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024
- Primary completion31 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two gropus planned for study 1. group - Hyperbaric spinal anesthesia 2. group - Hypobaric spinal anesthesia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417203
- Sponsor's protocol ID
- 11.05.2024-ADYU-ANS-NY-05
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index?
- ClinicalTrials.gov ID
- NCT06417203
- Acronym / sponsor ID
- 11.05.2024-ADYU-ANS-NY-05
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two gropus planned for study 1. group - Hyperbaric spinal anesthesia 2. group - Hypobaric spinal anesthesia
| Arm | Type | Receives |
|---|---|---|
| Hyberbaric group | Experimental | Procedure: spinal anesthesia with hyberbaric bupivacaineIn this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery |
| Hypobaric group | Experimental | Procedure: spinal anesthesia with hypobaric bupivacaineIn this group, hypobaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- 18-65 aged
Key exclusion criteria (7 listed)
- ASA III-IV
- Deny to participiate
- conditions that spinal anesthesia contraindicated
- use of alpha or beta-blockers
- allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesia with hyberbaric bupivacaineAfter 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) | Procedure or surgery | Hyberbaric group |
| spinal anesthesia with hypobaric bupivacaineAfter 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) | Procedure or surgery | Hypobaric group |
Primary outcome
Visual analog pain score (VAS)
Time frame: 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
1 secondary outcome
Quality of recovery (QoR-15)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia with hyberbaric bupivacaine and spinal anesthesia with hypobaric bupivacaine in people with Post Operative Pain, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog pain score (VAS) (time frame: 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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.