Postoperative PainNCT06221319
EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON TOTAL HIP ARTHROPLASTY
A study testing sacral erectör spinae plane group in people with Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- sacral erectör spinae plane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2024to 15 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo unilateral THA
- Spinal anesthesia
- 18-80-year-old patients
- Patients with ASA I-IV
- Patients who will stay in the hospital for at least 24 hours
Who cannot join
- 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
Show all 9Show fewer
- Patients using anticoagulants
- Patients with infection in the area to be treated
- Emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON RECOVERY QUALITY AFTER TOTAL HIP ARTHROPLASTY
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.
Read the detailed description
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. The investigators 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.
Anesthesia Technique and Analgesia Protocol a standard to measure postoperative pain severity after THA, and intravenous injection is used as a standard in patients with no contraindications within the scope of the multimodal analgesia protocol. paracetamol 1 gr. 3x1 + Dexketoprofen 50 mg 2x1 and when NRS is 3 and above, 1mg/kg tramadol is administered as a rescue analgesic. In addition, ESPB is applied to patients as a part of multimodal analgesia after THA surgery, unless there are contraindications in the hospitals where the study will be conducted. And 4 mg IV is routinely administered to patients with postoperative nausea and vomiting. Ondansetron is administered . All patients will receive routine monitoring and routine anesthesia management. 20 gauge to patients Intravenous ( IV ) cannulation is provided and 15ml/kg/ h Isotonic fluid will be started. The spinal anesthesia will be applied to the patients by administering 3cc of 0.5% bupivacaine through the L3-L4 or L4-L5 intervertebral space. Patients will then be released to the surgical team for THA surgery. After the surgical procedure is completed, patients will be transferred to the postanesthetic care unit (PACU) for observation. S-ESPB will be applied to patients in Group S
- Conditions
- Postoperative Pain
- Being tested
- sacral erectör spinae plane group
- Keywords
- pain, interfascial plan block.
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral erectör spinae plane groupOther
sacral erectör spinae plane will be applied to patients in Group S
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Group 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 comparator | sacral erector spinae plane will be applied to patients in Group S Receives: Other: sacral erectör spinae plane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start24 Jan 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221319
- Sponsor's protocol ID
- total hıp arthroplasty
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON RECOVERY QUALITY AFTER TOTAL HIP ARTHROPLASTY
- ClinicalTrials.gov ID
- NCT06221319
- Acronym / sponsor ID
- total hıp arthroplasty
- Conditions
- Postoperative Pain
- Keywords
- pain, interfascial plan block.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 24 Jan 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.
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.
Detailed description
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. The investigators 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.
Anesthesia Technique and Analgesia Protocol a standard to measure postoperative pain severity after THA, and intravenous injection is used as a standard in patients with no contraindications within the scope of the multimodal analgesia protocol. paracetamol 1 gr. 3x1 + Dexketoprofen 50 mg 2x1 and when NRS is 3 and above, 1mg/kg tramadol is administered as a rescue analgesic. In addition, ESPB is applied to patients as a part of multimodal analgesia after THA surgery, unless there are contraindications in the hospitals where the study will be conducted. And 4 mg IV is routinely administered to patients with postoperative nausea and vomiting. Ondansetron is administered . All patients will receive routine monitoring and routine anesthesia management. 20 gauge to patients Intravenous ( IV ) cannulation is provided and 15ml/kg/ h Isotonic fluid will be started. The spinal anesthesia will be applied to the patients by administering 3cc of 0.5% bupivacaine through the L3-L4 or L4-L5 intervertebral space. Patients will then be released to the surgical team for THA surgery. After the surgical procedure is completed, patients will be transferred to the postanesthetic care unit (PACU) for observation. S-ESPB will be applied to patients in Group S
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Group 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 comparator | Other: sacral erectör spinae plane groupsacral erector spinae plane will be applied to patients in Group S |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who will undergo unilateral THA
- Spinal anesthesia
- 18-80-year-old patients
- Patients with ASA I-IV
- Patients who will stay in the hospital for at least 24 hours
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| sacral erectör spinae plane groupsacral erectör spinae plane will be applied to patients in Group S | Other | Sacral erektör spinae plane group |
Primary outcome
Quality of recovery-15T
Time frame: One day
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 .
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 16 Apr 2024.
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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 sacral erectör spinae plane group in people with Postoperative Pain, run by Konya City 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 5 inclusion and 9 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 16 Apr 2024. 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?
Quality of recovery-15T (time frame: One day). 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 16 Apr 2024.