Postoperative Pain Following Modified Radical Mastectomy for Breast CancerNCT06548646
Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Pain Control After Modified Radical Mastectomy
A study testing Thoracic Interfascial Plane Block and Erector Spinae Plane Block in people with Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer, run by Safie ramez tewfeik abd el moneim at 1 site in Egypt.
Trial summary
This study compares two methods of local pain control in patients undergoing Modified Radical Mastectomy, a common surgery for breast cancer( tumor in the breast) treatment. It aims to determine which method, the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block, provides better pain relief after… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer
- What is being tested?
- Thoracic Interfascial Plane Block and Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 20 Jun 2026
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients older than 21 years old
- American Society of Anesthesiologists (ASA) physical status II.
Who cannot join
- Known allergy to one of the study medications.
- Skin infections at the site of the needle puncture.
- Significant organ dysfunction (hepatic, renal, or cardiac dysfunction), coagulopathy or recent anticoagulant use, epilepsy.
- Patients diagnosed with obstructive sleep apnoea, pulmonary compromise .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Postoperative Pain Control in Patients Undergoing Modified Radical Mastectomy
This study compares two methods of local pain control in patients undergoing Modified Radical Mastectomy, a common surgery for breast cancer( tumor in the breast) treatment. It aims to determine which method, the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block, provides better pain relief after surgery, reduces side effects,decrease the incidence of persistent pain,improve quality of life and increases patient satisfaction.
Why This Study Is Important:
Read more
Breast cancer surgery can cause significant pain, and managing this pain is important for a quick recovery. Currently, pain is often managed with opioids, which can cause side effects like nausea and drowsiness. investigators want to find a method that controls pain effectively with fewer side effects, helping patients recover faster and feel better.
Who Can Take Part:
Women aged 21 and older who are scheduled for a Modified Radical Mastectomy at Ain Shams University hospitals can participate in this study.
What Will Happen During the Study:
Participants will be randomly assigned to receive either the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block before surgery.
Pain levels will be measured using a numerical pain score from 1 to 10. Researchers will track the amount of pain medication needed, the time it takes to feel pain relief, and any side effects.
Other factors such as time to start walking again, and overall satisfaction with pain control will also be recorded.long term outcomes such as Persistent pain, Brief Pain Inventory interference, DN4-interview score, analgesic use and quality of life at 3 and 6 months.
What investigators hope to Learn:
Investigators hope to find out which nerve block provides better pain relief after surgery. By comparing TIPB and ESPB, with the aim to identify the method that:
Requires less additional pain medication Has fewer side effects Improves sleep quality and overall recovery Increases patient satisfaction
Significance:
This study could lead to better pain management strategies for breast cancer surgery, reducing the need for opioids and enhancing patient recovery and comfort, and improving long term satisfaction and quality of life.
Participation:
Participants will be monitored closely during and after the procedure to ensure their safety and well-being. The results of this study could help improve pain management for future patients undergoing similar surgeries.
Read the detailed description
This study is a randomized, double-blinded clinical trial comparing the efficacy of two ultrasound-guided nerve blocks for postoperative pain management in patients undergoing Modified Radical Mastectomy (MRM). The two techniques under investigation are the Thoracic Interfascial Plane Block (TIPB) and the Erector Spinae Plane Block (ESPB). Both nerve blocks are administered to provide targeted pain relief by numbing specific nerves involved in the surgical area.
Methodology:
Participants will be randomly assigned to one of two groups to receive either TIPB or ESPB. The randomization will ensure unbiased distribution of participants across both groups. The nerve blocks will be administered preoperatively under ultrasound guidance to ensure accurate placement and effectiveness.
Assessments and Measurements:
Pain levels will be assessed using the Visual Analog Scale (VAS) at multiple time points postoperatively, including at rest and during movement. The primary outcome measure is the total amount of rescue pain medication required within the first 48 hours after surgery. Secondary outcomes include the time to first rescue analgesic, intraoperative fentanyl consumption, hemodynamic parameters, sleep quality, time to first ambulation, VAS scores for pain and nausea, and overall patient satisfaction. Persistent pain, Brief Pain Inventory interference, DN4-interview score, analgesic use and quality of life will be assessed by blinded interview at 3 and 6 months
Safety and Monitoring:
Participants will be monitored for adverse events, including complications related to the nerve block techniques. Hemodynamic parameters, such as blood pressure and heart rate, will be closely observed during the perioperative period to ensure patient safety.
Significance:
The findings from this study aim to identify a short and long term superior pain management strategy that minimizes opioid consumption, reduces side effects, and enhances recovery and patient satisfaction following MRM. If successful, the results could inform clinical practice and improve postoperative care for breast cancer patients.
This study is conducted at Ain Shams University hospitals and adheres to ethical guidelines to ensure the safety and well-being of all participants.
- Being tested
- Thoracic Interfascial Plane Block, Erector Spinae Plane Block
- Keywords
- breast cancer, Modified Radical Mastectomy, Mastectomy, postoperative pain, Erector Spinae Plane Block, Thoracic Interfascial Plane Block
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Interfascial Plane BlockProcedure or surgery
Also called Thoracic Nerve Block, TIPB
The Thoracic Interfascial Plane Block (TIPB) is a regional anesthesia technique used to manage postoperative pain, particularly in thoracic and breast surgeries. This block involves the injection of a local anesthetic into the fascial plane between the thoracic muscles, targeting the nerves that supply the chest wall and upper abdominal area. It includes Pecto-Intercostal Fascial Plane Block (PIFB) and Serratus Intercostal Fascial Plane Block (SIFB).
Erector Spinae Plane BlockProcedure or surgery
Also called ESPB
The Erector Spinae Plane Block (ESPB) is a regional anesthesia technique used to manage pain, particularly in thoracic and abdominal surgeries. This block involves the injection of a local anesthetic into the plane between the erector spinae muscle and the transverse processes of the vertebrae.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Interfascial Plane Block | Experimental | the Thoracic Interfascial Plane Block, which includes Pecto-Intercostal Fascial Plane Block and Serratus Intercostal Fascial Plane Block, is a peripheral nerve block that targets the intercostal nerve branches scattered throughout the chest and axilla Receives: Procedure: Thoracic Interfascial Plane Block |
| Erector Spinae Plane Block | Active comparator | Erector Spinae Plane Block (ESPB) is an anesthesia technique for providing effective analgesia during and after breast and abdominal surgery Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of rescue pain medication required within the first 48 hours after surgery
Researchers will report the total amount of analgesia used in the first 48 hours after surgery
Measured: 48 hours
Secondary outcomes (12)
Time to first rescue analgesia'
The time at which the first analgesia is adminstered after surgery
Measured: 48 hours
Total intraoperative fentanyl consumption
The total intraoperative consumption of fentanyl
Measured: Total intraoperative time of surgery
Time for the first ambulation
The time at which the patient will be first be able to ambulate from bed.
Measured: 48 hours
VAS score for pain
The postoperative pain using The Visual Analogue Scale (VAS) from 0 to 10, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be).
Measured: 48 hours
VAS score for nausea
nausea during the postoperative period using Visual Analogue Scale (VAS) with two endpoints representing 0 ('no nausea') and 10 ('nausea as bad as it could be')
Measured: 48 hours
Patient Satisfaction score
(five-point Likert scale) where (1 = extremely dissatisfied to 5 = extremely satisfied) to measure postoperative patient satisfaction.
Measured: 48 hours
presence of persistent pain
pain in the operated breast, chest wall, axilla or ipsilateral arm that had been present since surgery and was not explained by local recurrence, infection or another identifiable cause on a 0-10 numerical rating scale
Measured: 3 months and 6 months
Pain interference
The seven interference items of the Brief Pain Inventory (general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life; each scored 0-10) were recorded, and the interference score was calculated as their mean
Measured: 3 months and 6 months
Neuropathic symptoms
Douleur Neuropathique 4 questionnaire (DN4-interview; range 0-7), a score of 3 or more indicated neuropathic pain
Measured: 3 and 6 months
Analgesic use and pain-clinic attendance
Patients were asked which medicines they were taking for surgical-site pain and at what daily dose and number of visits to pain-management clinic which then confirmed by hospital registry ,clinic and pharmacy records
Measured: 3 and 6 months
Patient Global Impression of Change
recorded on a seven-point scale from 1 (very much improved) to 7 (very much worse); scores of 1 or 2 were considered a clinically important improvement.
Measured: 3 and 6 months
Health-related quality of life
EORTC QLQ-C30 and its breast cancer module (QLQ-BR23) validated Arabic versions
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Nov 2024
- Primary completion1 Dec 2025
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Following Modified Radical Mastectomy for Breast CancerStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Safie ramez tewfeik abd el moneim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Safie ramez tewfeik abd el moneim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548646
- Sponsor's protocol ID
- MD178/2023
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaur U, Shamshery C, Agarwal A, Prakash N, Valiveru RC, Mishra P. Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks. Korean J Anesthesiol. 2020 Oct;73(5):425-433. doi: 10.4097/kja.20159. Epub 2020 Sep 24.
PubMed 32987492Hong B, Yoon SH, Youn AM, Kim BJ, Song S, Yoon Y. Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Korean J Anesthesiol. 2017 Apr;70(2):209-212. doi: 10.4097/kjae.2017.70.2.209. Epub 2017 Jan 12.
PubMed 28367293Zhang H, Miao Y, Qu Z. Refining a great idea: the consolidation of PECS I, PECS II and serratus blocks into a single thoracic fascial plane block, the SAP block-a concern on the muscle pain. Reg Anesth Pain Med. 2020 Jun;45(6):480. doi: 10.1136/rapm-2019-101042. Epub 2019 Oct 25. No abstract available.
PubMed 31653798Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
PubMed 10757584
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Postoperative Pain Control in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT06548646
- Acronym / sponsor ID
- MD178/2023
- Keywords
- breast cancer, Modified Radical Mastectomy, Mastectomy, postoperative pain, Erector Spinae Plane Block, Thoracic Interfascial Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Safie ramez tewfeik abd el moneimUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 12 Aug 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.
This study compares two methods of local pain control in patients undergoing Modified Radical Mastectomy, a common surgery for breast cancer( tumor in the breast) treatment. It aims to determine which method, the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block, provides better pain relief after surgery, reduces side effects,decrease the incidence of persistent pain,improve quality of life and increases patient satisfaction.
Why This Study Is Important:
Breast cancer surgery can cause significant pain, and managing this pain is important for a quick recovery. Currently, pain is often managed with opioids, which can cause side effects like nausea and drowsiness. investigators want to find a method that controls pain effectively with fewer side effects, helping patients recover faster and feel better.
Who Can Take Part:
Women aged 21 and older who are scheduled for a Modified Radical Mastectomy at Ain Shams University hospitals can participate in this study.
What Will Happen During the Study:
Participants will be randomly assigned to receive either the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block before surgery.
Pain levels will be measured using a numerical pain score from 1 to 10. Researchers will track the amount of pain medication needed, the time it takes to feel pain relief, and any side effects.
Other factors such as time to start walking again, and overall satisfaction with pain control will also be recorded.long term outcomes such as Persistent pain, Brief Pain Inventory interference, DN4-interview score, analgesic use and quality of life at 3 and 6 months.
What investigators hope to Learn:
Investigators hope to find out which nerve block provides better pain relief after surgery. By comparing TIPB and ESPB, with the aim to identify the method that:
Requires less additional pain medication Has fewer side effects Improves sleep quality and overall recovery Increases patient satisfaction
Significance:
This study could lead to better pain management strategies for breast cancer surgery, reducing the need for opioids and enhancing patient recovery and comfort, and improving long term satisfaction and quality of life.
Participation:
Participants will be monitored closely during and after the procedure to ensure their safety and well-being. The results of this study could help improve pain management for future patients undergoing similar surgeries.
Detailed description
This study is a randomized, double-blinded clinical trial comparing the efficacy of two ultrasound-guided nerve blocks for postoperative pain management in patients undergoing Modified Radical Mastectomy (MRM). The two techniques under investigation are the Thoracic Interfascial Plane Block (TIPB) and the Erector Spinae Plane Block (ESPB). Both nerve blocks are administered to provide targeted pain relief by numbing specific nerves involved in the surgical area.
Methodology:
Participants will be randomly assigned to one of two groups to receive either TIPB or ESPB. The randomization will ensure unbiased distribution of participants across both groups. The nerve blocks will be administered preoperatively under ultrasound guidance to ensure accurate placement and effectiveness.
Assessments and Measurements:
Pain levels will be assessed using the Visual Analog Scale (VAS) at multiple time points postoperatively, including at rest and during movement. The primary outcome measure is the total amount of rescue pain medication required within the first 48 hours after surgery. Secondary outcomes include the time to first rescue analgesic, intraoperative fentanyl consumption, hemodynamic parameters, sleep quality, time to first ambulation, VAS scores for pain and nausea, and overall patient satisfaction. Persistent pain, Brief Pain Inventory interference, DN4-interview score, analgesic use and quality of life will be assessed by blinded interview at 3 and 6 months
Safety and Monitoring:
Participants will be monitored for adverse events, including complications related to the nerve block techniques. Hemodynamic parameters, such as blood pressure and heart rate, will be closely observed during the perioperative period to ensure patient safety.
Significance:
The findings from this study aim to identify a short and long term superior pain management strategy that minimizes opioid consumption, reduces side effects, and enhances recovery and patient satisfaction following MRM. If successful, the results could inform clinical practice and improve postoperative care for breast cancer patients.
This study is conducted at Ain Shams University hospitals and adheres to ethical guidelines to ensure the safety and well-being of all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Interfascial Plane Block | Experimental | Procedure: Thoracic Interfascial Plane Blockthe Thoracic Interfascial Plane Block, which includes Pecto-Intercostal Fascial Plane Block and Serratus Intercostal Fascial Plane Block, is a peripheral nerve block that targets the intercostal nerve branches scattered throughout the chest and axilla |
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockErector Spinae Plane Block (ESPB) is an anesthesia technique for providing effective analgesia during and after breast and abdominal surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients older than 21 years old
- American Society of Anesthesiologists (ASA) physical status II.
Key exclusion criteria (4 listed)
- Known allergy to one of the study medications.
- Skin infections at the site of the needle puncture.
- Significant organ dysfunction (hepatic, renal, or cardiac dysfunction), coagulopathy or recent anticoagulant use, epilepsy.
- Patients diagnosed with obstructive sleep apnoea, pulmonary compromise .
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 |
|---|---|---|
| Thoracic Interfascial Plane BlockAlso: Thoracic Nerve Block, TIPBThe Thoracic Interfascial Plane Block (TIPB) is a regional anesthesia technique used to manage postoperative pain, particularly in thoracic and breast surgeries. This block involves the injection of a local anesthetic into the fascial plane between the thoracic muscles, targeting the nerves that supply the chest wall and upper abdominal area. It includes Pecto-Intercostal Fascial Plane Block (PIFB) and Serratus Intercostal Fascial Plane Block (SIFB). | Procedure or surgery | Thoracic Interfascial Plane Block |
| Erector Spinae Plane BlockAlso: ESPBThe Erector Spinae Plane Block (ESPB) is a regional anesthesia technique used to manage pain, particularly in thoracic and abdominal surgeries. This block involves the injection of a local anesthetic into the plane between the erector spinae muscle and the transverse processes of the vertebrae. | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Total amount of rescue pain medication required within the first 48 hours after surgery
Time frame: 48 hours
Researchers will report the total amount of analgesia used in the first 48 hours after surgery
12 secondary outcomes
Time to first rescue analgesia'
Time frame: 48 hours
Total intraoperative fentanyl consumption
Time frame: Total intraoperative time of surgery
Time for the first ambulation
Time frame: 48 hours
VAS score for pain
Time frame: 48 hours
VAS score for nausea
Time frame: 48 hours
Patient Satisfaction score
Time frame: 48 hours
presence of persistent pain
Time frame: 3 months and 6 months
Pain interference
Time frame: 3 months and 6 months
Neuropathic symptoms
Time frame: 3 and 6 months
Analgesic use and pain-clinic attendance
Time frame: 3 and 6 months
Patient Global Impression of Change
Time frame: 3 and 6 months
Health-related quality of life
Time frame: 3 and 6 months
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 Oct 2026.
- Background: PubMed 32987492Kaur U, Shamshery C, Agarwal A, Prakash N, Valiveru RC, Mishra P. Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks. Korean J Anesthesiol. 2020 Oct;73(5):425-433. doi: 10.4097/kja.20159. Epub 2020 Sep 24.
- Background: PubMed 28367293Hong B, Yoon SH, Youn AM, Kim BJ, Song S, Yoon Y. Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Korean J Anesthesiol. 2017 Apr;70(2):209-212. doi: 10.4097/kjae.2017.70.2.209. Epub 2017 Jan 12.
- Background: PubMed 31653798Zhang H, Miao Y, Qu Z. Refining a great idea: the consolidation of PECS I, PECS II and serratus blocks into a single thoracic fascial plane block, the SAP block-a concern on the muscle pain. Reg Anesth Pain Med. 2020 Jun;45(6):480. doi: 10.1136/rapm-2019-101042. Epub 2019 Oct 25. No abstract available.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 10757584Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
- 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.
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 Thoracic Interfascial Plane Block and Erector Spinae Plane Block in people with Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer, run by Safie ramez tewfeik abd el moneim 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 2 inclusion and 4 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 Oct 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?
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?
Total amount of rescue pain medication required within the first 48 hours after surgery (time frame: 48 hours). 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 NCT06548646, which also lists 5 linked publications.
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 Oct 2026.