CholecystectomyNCT06058195
Comparison of Quadratus Lumborum and Transverse Abdominis Plane Blocks With Intravenous Analgesic in Gallbladder Surgery
An observational study of Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients who will undergo laparoscopic gallbladder surgery are expected to experience less postoperative pain and have less need for morphine-derived painkillers. For this reason, a total of 128 patients were planned to be included in the study, including a group of patients who were eligible for gallbladder surgery… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Quadratus lumborum plane block, Transverse abdominis plane block and Intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2023to 16 Feb 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo laparoscopic cholecystectomy surgery.
Who may be able to join
- Aged 18-70 years,
- who will undergo laparoscopic cholecystectomy and who meet the American Society of Anesthesiologists (ASA) I-III physical status
Who cannot join
- American Society of Anesthesiologists (ASA) physical status above 3
- Age < 18 or >70 years
- patient's reluctance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, 21070
Fatma Acil, M.D., +905337225225, acilfatma@gmail.com
About this study
Official title: Comparison of the Efficacy of Bilateral Transverse Abdominis Plane Block (TAPB) and Bilateral Quadratus Lumborum Block (QLB) With Intravenous Analgesic (IVA) Group for Preemptive Analgesia in Laparoscopic Cholecystectomy Surgery
Patients who will undergo laparoscopic gallbladder surgery are expected to experience less postoperative pain and have less need for morphine-derived painkillers.
For this reason, a total of 128 patients were planned to be included in the study, including a group of patients who were eligible for gallbladder surgery with transverse abdominis plane block (TAPB), a group of patients with quadratus lumborum plane block (QLB) and a group of patients with intravenous painkillers (IVA).
Read the detailed description
- Group QLB (Quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia.
- Group TAPB (Transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia. For both Group QLB and Group TAPB block group;
- Medical records will be audited to monitor adherence to the intervention.
- each patient will be administered 0.25% bupivacaine for each side (a total of 40 ml of 0.25% bupivacaine will be used)
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face.
- Plane block applications will be applied only once in the preoperative period.
- In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.
- This study will be followed up in the general surgery unit.
- Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
- Both plane blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.
- Group IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia.
- Postoperative evaluations of patients will be performed face to face.
- Plane block applications will be applied only once in the preoperative period.
- In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.
- This study will be followed up in the general surgery unit.
- Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
Statistical methods / analysis: Power analysis (G-Power version 3.1.9.4 (University Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 52.
SPSS 16.0 for Windows (SPSS Inc., Chicago, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.
- Conditions
- Cholecystectomy
- Being tested
- Quadratus lumborum plane block, Transverse abdominis plane block, Intravenous analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum plane blockProcedure or surgery
QLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied.
Transverse abdominis plane blockProcedure or surgery
TAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied.
Intravenous analgesiaProcedure or surgery
IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group QLB (quadratus lumborum plane block) | Group QLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied.
- Plane block applications will be applied only once in the preoperative period Receives: Procedure: Quadratus lumborum plane block | |
| Group TAPB (transverse abdominis plane block) | Group TAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Receives: Procedure: Transverse abdominis plane block | |
| Group IVA (Intravenous analgesia) | Group IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia. Receives: Procedure: Intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS value of abdominal pain
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: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
postoperative total tramadol consumption
Amount of tramadol used postoperatively (milligrams). If the VAS value of the patients is 4 and above, 100 mg tramadol is administered intravenously.
Measured: during the first 24 hours after surgery.
Secondary outcomes (7)
Sedation- agitation level
The Richmond Agitation Sedation Scale (RASS): identifies seven levels of sedation and agitation, which range from dangerous agitation to deep sedation, with a thorough description of patient behavior.
The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.
Measured: during extubation
amount of fentanyl consumed during the operation
micrograms of fentanyl consumed during surgery
Measured: during surgery
nausea-vomiting
questioning about the presence/absence of nausea and/or vomiting in the postoperative period
Measured: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
postoperative shoulder pain
shoulder pain patients will be asked to verbally assess whether there is pain or not
Measured: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
surgical duration
Time in hours from the start of the surgical incision until the last surgical suture is placed
Measured: at the end of surgery
anaesthesia duration
time in hours from induction of anaesthesia to extubation
Measured: at the end of anaesthesia
length of hospital stay
days of hospitalisation after the operation
Measured: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start3 Oct 2023
- Primary completion15 Feb 2024 (estimated)
- Study completion16 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058195
- Sponsor's protocol ID
- 03.03.2023/372
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.
PubMed 31649394
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Bilateral Transverse Abdominis Plane Block (TAPB) and Bilateral Quadratus Lumborum Block (QLB) With Intravenous Analgesic (IVA) Group for Preemptive Analgesia in Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06058195
- Acronym / sponsor ID
- 03.03.2023/372
- Conditions
- Cholecystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 16 Feb 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
Patients who will undergo laparoscopic gallbladder surgery are expected to experience less postoperative pain and have less need for morphine-derived painkillers.
For this reason, a total of 128 patients were planned to be included in the study, including a group of patients who were eligible for gallbladder surgery with transverse abdominis plane block (TAPB), a group of patients with quadratus lumborum plane block (QLB) and a group of patients with intravenous painkillers (IVA).
Detailed description
- Group QLB (Quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia.
- Group TAPB (Transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia. For both Group QLB and Group TAPB block group;
- Medical records will be audited to monitor adherence to the intervention.
- each patient will be administered 0.25% bupivacaine for each side (a total of 40 ml of 0.25% bupivacaine will be used)
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face.
- Plane block applications will be applied only once in the preoperative period.
- In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.
- This study will be followed up in the general surgery unit.
- Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
- Both plane blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.
- Group IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia.
- Postoperative evaluations of patients will be performed face to face.
- Plane block applications will be applied only once in the preoperative period.
- In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.
- This study will be followed up in the general surgery unit.
- Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
Statistical methods / analysis: Power analysis (G-Power version 3.1.9.4 (University Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 52.
SPSS 16.0 for Windows (SPSS Inc., Chicago, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group QLB (quadratus lumborum plane block) | – | Procedure: Quadratus lumborum plane blockGroup QLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. - Plane block applications will be applied only once in the preoperative period |
| Group TAPB (transverse abdominis plane block) | – | Procedure: Transverse abdominis plane blockGroup TAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. |
| Group IVA (Intravenous analgesia) | – | Procedure: Intravenous analgesiaGroup IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo laparoscopic cholecystectomy surgery.
Key inclusion criteria (2 listed)
- Aged 18-70 years,
- who will undergo laparoscopic cholecystectomy and who meet the American Society of Anesthesiologists (ASA) I-III physical status
Key exclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status above 3
- Age < 18 or >70 years
- patient's reluctance
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 |
|---|---|---|
| Quadratus lumborum plane blockQLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. | Procedure or surgery | Group QLB (quadratus lumborum plane block) |
| Transverse abdominis plane blockTAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. | Procedure or surgery | Group TAPB (transverse abdominis plane block) |
| Intravenous analgesiaIVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia. | Procedure or surgery | Group IVA (Intravenous analgesia) |
Primary outcome
VAS value of abdominal pain
Time frame: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
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."
postoperative total tramadol consumption
Time frame: during the first 24 hours after surgery.
Amount of tramadol used postoperatively (milligrams). If the VAS value of the patients is 4 and above, 100 mg tramadol is administered intravenously.
7 secondary outcomes
Sedation- agitation level
Time frame: during extubation
amount of fentanyl consumed during the operation
Time frame: during surgery
nausea-vomiting
Time frame: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
postoperative shoulder pain
Time frame: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
surgical duration
Time frame: at the end of surgery
anaesthesia duration
Time frame: at the end of anaesthesia
length of hospital stay
Time frame: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 31649394Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.
- 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.
Fatma Acil principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and 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 3 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 24 Jan 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 Fatma Acil (+905337225225, acilfatma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS value of abdominal pain (time frame: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058195, which also lists 1 linked publication.
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 24 Jan 2024.