Post Operative PainNCT06417723
Effect of Maxillary Nerve Block for Septoplasty
A study testing Maxillary nerve block 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 determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and… 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?
- Maxillary nerve block
- 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 , Septoplasty patints
Who cannot join
- ASA III-IV
- Deny to participte in study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adıyaman Training and Research Hospital
Adıyaman, 02200
Nezir YILMAZ, Dr, +905068939496, yilmaznezir@hotmail.com
Nezir YILMAZ, Dr
About this study
The aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.
Read the detailed description
Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study.
The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups.
Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.
- Conditions
- Post Operative Pain
- Being tested
- Maxillary nerve block
- Keywords
- postoperative pain, maxillary nerve block, septoplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary nerve blockProcedure or surgery
It is aimed to reach the maxillary nerve trace with a peripheral nerve block needle using the suprazigomatic approach and to create a temporary block in the maxillary nerve with local anaesthetic injection.
| Study group | Role | What they receive |
|---|---|---|
| Block group | Experimental | Bilateral maxillary nerve block was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded . Receives: Procedure: Maxillary nerve block |
| Control group | No intervention | No intevention was planned for this group. Only genaeral anesthesia applications will use for surgery. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded . |
What is being measured
The primary outcome is the main question the study is designed to answer.
The visual analog pain score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: three months
Secondary outcomes (1)
Quality of recovery (QoR -15)
The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
Measured: three months
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 (estimated)
- Study completion15 Sep 2024 (estimated)
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 groups designed from septoplasty patintes for study. 1. only general anesthesia 2. General anesthesia + maxillary nerve block
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
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
- NCT06417723
- Sponsor's protocol ID
- ADYU-ANS-NY-04
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maxillary Nerve Block for Septoplasty
- ClinicalTrials.gov ID
- NCT06417723
- Acronym / sponsor ID
- ADYU-ANS-NY-04
- Conditions
- Post Operative Pain
- Keywords
- postoperative pain, maxillary nerve block, septoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- 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 determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.
Detailed description
Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study.
The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups.
Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two groups designed from septoplasty patintes for study. 1. only general anesthesia 2. General anesthesia + maxillary nerve block
| Arm | Type | Receives |
|---|---|---|
| Block group | Experimental | Procedure: Maxillary nerve blockBilateral maxillary nerve block was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded . |
| Control group | No intervention | –No intevention was planned for this group. Only genaeral anesthesia applications will use for surgery. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II , Septoplasty patints
Key exclusion criteria (2 listed)
- ASA III-IV
- Deny to participte in study
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 |
|---|---|---|
| Maxillary nerve blockIt is aimed to reach the maxillary nerve trace with a peripheral nerve block needle using the suprazigomatic approach and to create a temporary block in the maxillary nerve with local anaesthetic injection. | Procedure or surgery | Block group |
Primary outcome
The visual analog pain score
Time frame: three months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
1 secondary outcome
Quality of recovery (QoR -15)
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary nerve block 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 1 inclusion and 2 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 23 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nezir Yılmaz (05068939496, yilmaznezirr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The visual analog pain score (time frame: three months). 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 23 Aug 2024.