Recovery of PostoperativeNCT05406128
The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety
A study testing preoperative erector spina plane block and intraoperative erector spina plane block in people with Recovery of Postoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
we aimed to compare the effect of preoperative awake or post-induction erector spina plane block on patient anxiety and recovery quality in patients who will undergo elective lumbar disc hernioplasty. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Recovery of Postoperative
- What is being tested?
- preoperative erector spina plane block and intraoperative erector spina plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2022to 1 Oct 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years old
- American Society of Anesthesiologists score I-II-III
- Patients who can read and write
- Can speak Turkish language clearly
Who cannot join
- Visual and hearing impaired
- Those with dementia
- Known serious heart, kidney and liver diseases
- Life-threatening hematological diseases
- Central and peripheral neurological diseases
- Psychiatric disorders
Show all 13Show fewer
- History of allergy to amide type local anesthetics
- Infection in the block area
- Bleeding diathesis
- Morbidly obese (patients with BMI 40 and above)
- A history of narcotic drug use within 24 hours before the operation
- Those with narcotic substance and alcohol addiction related to chronic pain
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital
Ankara
fulya eser çelik, 03125526000 ext. 731039, lfulyaeser@hotmail.com
About this study
Official title: The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety in Cases of Lumbar Disc Hernioplasty
we aimed to compare the effect of preoperative awake or post-induction erector spina plane block on patient anxiety and recovery quality in patients who will undergo elective lumbar disc hernioplasty.
Read the detailed description
Postoperative recovery quality can be tested with the Quality of Recovery-40 (QoR-40) questionnaire. Preoperative anxiety can be detected through structured and standardized screening with the State-Trait Anxiety Inventory (STAI) I and II. In our study, 108 patients between the ages of 18-70 who were planned for lumbar disc hernioplasty will be included. Preoperative Quality of Recovery-40 (QoR40), STAI I and II scores (anxiety questionnaire) will be administered to each patient.The patients will be divided into two groups as preoperative ve intraoperative group. Erector spina plane block will be applied to preoperative group patients in the preoperative period. In the intraoperative group, erector spina plane block will be applied after anesthesia induction. The STAI and Quality of Recovery-40 (QoR40) questionnaire will be repeated postoperatively, the Numerical Rating Scale (NRS) and postoperative patient satisfaction will be measured.
- Conditions
- Recovery of Postoperative
- Being tested
- preoperative erector spina plane block, intraoperative erector spina plane block
- Keywords
- block timing, quality of recovery, erector spina plan block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative erector spina plane blockOther
Erector spina plane block will be applied to preoperative group patients in the preoperative period.
intraoperative erector spina plane blockOther
In the intraoperative group, erector spina plane block will be applied after anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| preoperative group | Active comparator | Erector spina plane block will be applied to preoperative group patients in the preoperative period. Receives: Other: preoperative erector spina plane block |
| intraoperative group | Active comparator | In the intraoperative group, erector spina plane block will be applied after anesthesia induction. Receives: Other: intraoperative erector spina plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of postoperative functional recovery (QoR-40) score
The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.
Measured: 24 hours
Secondary outcomes (2)
Spielberg State-Trait Anxiety Inventory (STAI) score
The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.
Measured: 4 hours
Numerical Rating Scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start7 Jun 2022 (estimated)
- Primary completion7 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery of PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fulya eser, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406128
- Sponsor's protocol ID
- anxiety
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety in Cases of Lumbar Disc Hernioplasty
- ClinicalTrials.gov ID
- NCT05406128
- Acronym / sponsor ID
- anxiety
- Conditions
- Recovery of Postoperative
- Keywords
- block timing, quality of recovery, erector spina plan block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 7 Jun 2022 (estimated)
- Primary completion
- 7 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 6 Jun 2022 (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.
we aimed to compare the effect of preoperative awake or post-induction erector spina plane block on patient anxiety and recovery quality in patients who will undergo elective lumbar disc hernioplasty.
Detailed description
Postoperative recovery quality can be tested with the Quality of Recovery-40 (QoR-40) questionnaire. Preoperative anxiety can be detected through structured and standardized screening with the State-Trait Anxiety Inventory (STAI) I and II. In our study, 108 patients between the ages of 18-70 who were planned for lumbar disc hernioplasty will be included. Preoperative Quality of Recovery-40 (QoR40), STAI I and II scores (anxiety questionnaire) will be administered to each patient.The patients will be divided into two groups as preoperative ve intraoperative group. Erector spina plane block will be applied to preoperative group patients in the preoperative period. In the intraoperative group, erector spina plane block will be applied after anesthesia induction. The STAI and Quality of Recovery-40 (QoR40) questionnaire will be repeated postoperatively, the Numerical Rating Scale (NRS) and postoperative patient satisfaction will be measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative group | Active comparator | Other: preoperative erector spina plane blockErector spina plane block will be applied to preoperative group patients in the preoperative period. |
| intraoperative group | Active comparator | Other: intraoperative erector spina plane blockIn the intraoperative group, erector spina plane block will be applied after anesthesia induction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-70 years old
- American Society of Anesthesiologists score I-II-III
- Patients who can read and write
- Can speak Turkish language clearly
Key exclusion criteria (13 listed)
- Visual and hearing impaired
- Those with dementia
- Known serious heart, kidney and liver diseases
- Life-threatening hematological diseases
- Central and peripheral neurological diseases
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 |
|---|---|---|
| preoperative erector spina plane blockErector spina plane block will be applied to preoperative group patients in the preoperative period. | Other | preoperative group |
| intraoperative erector spina plane blockIn the intraoperative group, erector spina plane block will be applied after anesthesia induction. | Other | intraoperative group |
Primary outcome
The quality of postoperative functional recovery (QoR-40) score
Time frame: 24 hours
The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.
2 secondary outcomes
Spielberg State-Trait Anxiety Inventory (STAI) score
Time frame: 4 hours
Numerical Rating Scale (NRS)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative erector spina plane block and intraoperative erector spina plane block in people with Recovery of Postoperative, run by Ankara City Hospital Bilkent 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fulya eser çelik (03125526000 ext. 731039, lfulyaeser@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of postoperative functional recovery (QoR-40) score (time frame: 24 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 6 Jun 2022.