Post Operative PainNCT06810206
A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC)
A study testing Bilateral Ultrasound Guidance M-TAPA and Bilateral Ultrasound Guidance EOIPB in people with Post Operative Pain, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus… 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?
- Bilateral Ultrasound Guidance M-TAPA and Bilateral Ultrasound Guidance EOIPB
- 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 siteEgypt
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18-65 years
- Scheduled for Laparoscopic cholecystectomy surgery
- ASA (American Society of Anaesthesiologists) physical status I-II
Who cannot join
- Known allergy to local anaesthetics
- Coagulopathy or anticoagulant use
- Infection at the site of block
- Chronic pain conditions
- Advanced liver or kidney failure
- History of abdominal surgery or trauma
Show all 12Show fewer
- Alcohol or drug use
- Refusal to participate
- Chronic opioid consumption
- Use of painkillers in the preoperative 24hours
- Conversion to open surgery
- Body mass index ( BMI ) > 35
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculity of medicine , Kasr Al Aini Hospitals , Cairo University
Cairo
Nora A Agiza, MD, 00201001881060, noraagiza@gmail.com
About this study
Official title: A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC): A Double-Blinded Randomized Comparative Study.
Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .
- Conditions
- Post Operative Pain
- Being tested
- Bilateral Ultrasound Guidance M-TAPA, Bilateral Ultrasound Guidance EOIPB
- Keywords
- postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Ultrasound Guidance M-TAPAOther
Also called Modified throacoabdominal plane block (M-TAPA), GROUP A
transversus abdominis, internal oblique, and external oblique muscles will be identified on the costochondral angle in the sagittal plane at the 10th costal margin. deep angle will be given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. The needle will be inserted in the cranial direction using the in-plane technique, and the needle tip will be moved to the posterior aspect of the 10th costal cartilage, and saline (5 ml) will be injected to confirm the location by observing dissection between internal oblique muscle and transversus abdominis muscle under the 10th costal cartilage, and local anesthetic will be injected into the lower surface of the chondrium. The local anesthetic to be used is bupivacaine 0.25% with Ultrasound Siemens® ACUSON X300 portable scanner with a high frequency linear transducer (10 MHz) using A Quincke 22 G . x 3½ in. (0.7x88 mm) A spinal needle
Bilateral Ultrasound Guidance EOIPBProcedure or surgery
Also called External Oblique Intercoastal Plane Block ( EOIPB ), GROUP B
The patients will be positioned in the supine position with the ipsilateral arm in abduction. The transducer will be positioned in a cephalad to caudad parasagittal plane at the anterior axillary line at the level of the sixth and seventh ribs in line with the xiphoid process. Using the in-plane technique, the needle will be advanced from cephalad to caudad until the tip lies in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs. Following hydro-dissection with 2 ml of 0.9% saline to confirm the correct needle tip position, LA injection will be given. The same procedure will then be repeated on the contralateral
- Local anesthetics to be injected: iBupivacaine (0.25%)
- Dose : 25ml on each side
- Device to be used: Ultrasound Siemens® ACUSON X300 portable scanner with a high-frequency linear transducer (10 MHz) that is covered in sterile plastic.
- Needle to be used : A Quincke 22 G . x 3½ inch (0.7x88 mm) spinal needle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: 30 patients will receive the MTAPA. Receives: Other: Bilateral Ultrasound Guidance M-TAPA |
| Group B | Active comparator | Group B: 30 patients will receive the EOIPB. Receives: Procedure: Bilateral Ultrasound Guidance EOIPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS
Numerical Rating Score (NRS) for Pain severity will be measured with a NRS of 0, being no pain , while of 10 being worst pain imaginable. NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period. (11) Patients will be educated and familiarized with NRS scores in the preoperative period. Postoperative, pain control regimen will be used for the two groups as Paracetamol 15mg/kg IV /6hours, Ketorolac 30mg IV /8hours. If the patient's NRS pain score happens to be ≥ 4 points, 10 mg of intravenous nalbuphine Will be given , and the NRS will be repeated again after 15 minutes , if still > 4 , additional 10 mg IV nalbuphine will be given , with maximum dose of 20 mg per dose , can be repeated up to four times per day with maximum dose of 80 mg per day (18)
Measured: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.
Secondary outcomes (9)
evaluating the quality of recovery via the QOR-40 questionnaire.
To evaluate the quality of recovery, the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU. Scores range from a minimum of 40 (poor recovery) to a maximum of 200 (excellent recovery).
Measured: the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU .
identifying dermatomal coverage of each block via pinprick test.
Dermatomal coverage will be tested using pinprick test to evaluate the T3-L1 sensory levels in PACU after evaluating the QoR-40 ( since block will be administered after induction of anaesthesia ) . Anterior and lateral cutaneous branches will be evaluated on a vertical line 3-5 cm from the midline and midaxillary lines, respectively. A 3-point numerical scale (0 = no pain, 1 = decreasing pain, 2 = normal pain) will be used. The values of 0 or 1 will be defined as effective . The normal sense in the shoulder will be used for comparison. (11,17)
Measured: Dermatomal coverage will be tested using pinprick test in PACU after evaluating the QoR-40 within the first hour postoperatively
evaluating the efficacy of each block in providing analgesia intraoperatively by measuring amount of fentanyl consumed in micrograms
- Anaesthesia induction and endotracheal intubation will be performed after preoxygenation with 100% oxygen, intravenously using propofol 2 mg/kg, fentanyl 1-2 µg/kg, and atracurium 0.5 mg/kg. Anaesthesia will be maintained with isoflurane (0.8-1.2 MAC) and atracurium 0.1mg/kg/20 mins
- additional boluses of fentanyl IV dose of 0.25 micrograms/kg/dose will be given if blood pressure and/or heart rate increase by 20% of baseline, with calculation of total fentanyl consumption intraoperatively in micrograms
Measured: intraoperatively
Total opioid consumption in the first 24 hours postoperatively in mgs
- Total Nalbuphine consumption will be recorded in mgs for a total of 24-hour period
- Postoperative pain control regimen will be used for the two groups as Paracetamol 15mg/kg IV / 6 hours, Ketorolac 30 mg IV/8 hours. If the patient's NRS pain score happens to be ≥ 4 points, 10 mg of intravenous nalbuphine Will be given , and the NRS will be repeated again after 15 minutes , if still > 4; additional 10 mg IV nalbuphine will be given , with maximum dose of 20 mg per dose that can be repeated up to four times per day with maximum dose of 80 mg per day
Measured: postoperatively with a total of 24 hour
Time to first mobilization in hours
●The time to mobilization of the patients following surgery will be recorded in hours Mobilization will be defined as being able to at least sit on the edge of the bed.
Measured: postoperatively up to 24 hour
Incidence of block-related complications
Incidence of block-related complications (e.g., hematoma, infection, nerve damage , LAST )
Measured: postoperatively with a total of 24 hour
Incidence of PONV.
●Verbal descriptive scale for Postoperative Nausea and Vomiting (PONV) will be used with 0 = none , 1 = mild nausea , 2= moderate nausea , 3= vomiting once , 4= multiple vomiting .
Measured: every six hours for a total of 24 hour postoperatively
the Time to first rescue opioid
the time to first rescue opioid will be noted and defined as the duration in hours that the patient lasted without the need of nalbuphine IV dose of 10 mg (NRS<4).
Measured: it will be measured postoperatively for a total period of 24 hour
time taken to adminsiter the block bilaterally
The time required to perform each bilateral block was recorded in minutes, beginning immediately after completion of skin sterilization and from the start of puncture to the end of LA infusion and ending upon completion of the bilateral local anesthetic injections.201 Block performance time was compared between the M-TAPA and EOIPB groups as an indicator of procedural feasibility and technical ease. In addition, the relationship between block performance time and patient BMI was evaluated to determine whether either technique is less affected by increasing BMI, thereby providing evidence regarding its ease of implementation in patients with higher body mass.
Measured: just after induction of anestheisa intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blinded, randomized comparative study with two parallel groups. Participants will be randomly assigned to receive either the MTAPA or the EOIPB.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miran Mohamed Abdelmagyd, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810206
- Sponsor's protocol ID
- MD-462-2024
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
PubMed 36307755
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC): A Double-Blinded Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT06810206
- Acronym / sponsor ID
- MD-462-2024
- Conditions
- Post Operative Pain
- Keywords
- postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 5 Feb 2025 (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.
Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a double-blinded, randomized comparative study with two parallel groups. Participants will be randomly assigned to receive either the MTAPA or the EOIPB.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Bilateral Ultrasound Guidance M-TAPAGroup A: 30 patients will receive the MTAPA. |
| Group B | Active comparator | Procedure: Bilateral Ultrasound Guidance EOIPBGroup B: 30 patients will receive the EOIPB. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years
- Scheduled for Laparoscopic cholecystectomy surgery
- ASA (American Society of Anaesthesiologists) physical status I-II
Key exclusion criteria (12 listed)
- Known allergy to local anaesthetics
- Coagulopathy or anticoagulant use
- Infection at the site of block
- Chronic pain conditions
- Advanced liver or kidney failure
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 |
|---|---|---|
| Bilateral Ultrasound Guidance M-TAPAAlso: Modified throacoabdominal plane block (M-TAPA), GROUP Atransversus abdominis, internal oblique, and external oblique muscles will be identified on the costochondral angle in the sagittal plane at the 10th costal margin. deep angle will be given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. The needle will be inserted in the cranial direction using the in-plane technique, and the needle tip will be moved to the posterior aspect of the 10th costal cartilage, and saline (5 ml) will be injected to confirm the location by observing dissection between internal oblique muscle and transversus abdominis muscle under the 10th costal cartilage, and local anesthetic will be injected into the lower surface of the chondrium. The local anesthetic to be used is bupivacaine 0.25% with Ultrasound Siemens® ACUSON X300 portable scanner with a high frequency linear transducer (10 MHz) using A Quincke 22 G . x 3½ in. (0.7x88 mm) A spinal needle | Other | Group A |
| Bilateral Ultrasound Guidance EOIPBAlso: External Oblique Intercoastal Plane Block ( EOIPB ), GROUP BThe patients will be positioned in the supine position with the ipsilateral arm in abduction. The transducer will be positioned in a cephalad to caudad parasagittal plane at the anterior axillary line at the level of the sixth and seventh ribs in line with the xiphoid process. Using the in-plane technique, the needle will be advanced from cephalad to caudad until the tip lies in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs. Following hydro-dissection with 2 ml of 0.9% saline to confirm the correct needle tip position, LA injection will be given. The same procedure will then be repeated on the contralateral * Local anesthetics to be injected: iBupivacaine (0.25%) * Dose : 25ml on each side * Device to be used: Ultrasound Siemens® ACUSON X300 portable scanner with a high-frequency linear transducer (10 MHz) that is covered in sterile plastic. * Needle to be used : A Quincke 22 G . x 3½ inch (0.7x88 mm) spinal needle | Procedure or surgery | Group B |
Primary outcome
comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS
Time frame: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.
Numerical Rating Score (NRS) for Pain severity will be measured with a NRS of 0, being no pain , while of 10 being worst pain imaginable. NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period. (11) Patients will be educated and familiarized with NRS scores in the preoperative period. Postoperative, pain control regimen will be used for the two groups as Paracetamol 15mg/kg IV /6hours, Ketorolac 30mg IV /8hours. If the patient's NRS pain score happens to be ≥ 4 points, 10 mg of intravenous nalbuphine Will be given , and the NRS will be repeated again after 15 minutes , if still > 4 , additional 10 mg IV nalbuphine will be given , with maximum dose of 20 mg per dose , can be repeated up to four times per day with maximum dose of 80 mg per day (18)
9 secondary outcomes
evaluating the quality of recovery via the QOR-40 questionnaire.
Time frame: the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU .
identifying dermatomal coverage of each block via pinprick test.
Time frame: Dermatomal coverage will be tested using pinprick test in PACU after evaluating the QoR-40 within the first hour postoperatively
evaluating the efficacy of each block in providing analgesia intraoperatively by measuring amount of fentanyl consumed in micrograms
Time frame: intraoperatively
Total opioid consumption in the first 24 hours postoperatively in mgs
Time frame: postoperatively with a total of 24 hour
Time to first mobilization in hours
Time frame: postoperatively up to 24 hour
Incidence of block-related complications
Time frame: postoperatively with a total of 24 hour
Incidence of PONV.
Time frame: every six hours for a total of 24 hour postoperatively
the Time to first rescue opioid
Time frame: it will be measured postoperatively for a total period of 24 hour
time taken to adminsiter the block bilaterally
Time frame: just after induction of anestheisa intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 36307755Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Ultrasound Guidance M-TAPA and Bilateral Ultrasound Guidance EOIPB in people with Post Operative Pain, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miran M Abdelaziz Raslan, MSC (00201140646969, miranrs1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS (time frame: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.). 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 NCT06810206, 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 20 Aug 2026.