Breast CancerPECS I vs SAPNCT07388238
Ultrasound-Guided PEC I vs SAP Block for Postoperative Analgesia in Modified Radical Mastectomy
A study testing Ultrasound-Guided Pectoral Nerve Block (PECS I) and Ultrasound-Guided Serratus Anterior Plane Block (SAPB) in people with Breast Cancer and Modified Radical Mastectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized double-blind controlled clinical trial was conducted to compare the analgesic efficacy of ultrasound-guided Pectoral Nerve Block versus Serratus Anterior Plane Block in female patients undergoing Modified Radical Mastectomy. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Modified Radical Mastectomy, Pectoral Nerve Blocks
- What is being tested?
- Ultrasound-Guided Pectoral Nerve Block (PECS I) and Ultrasound-Guided Serratus Anterior Plane Block (SAPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2021to 9 Dec 2021
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Physical status: ASA grades I and II
- Age between 35 and 60.
Who cannot join
- Known Allergy to one of the study drugs.
- Pregnant patients.
- Other Malignancy.
- History or evidence of coagulopathy, use of anti coagulant or anti platelet therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Anaethesia Department, Ain Shams University Hospital
Cairo, Cairo Governorate, 11517
About this study
Official title: Ultrasound Guided Pectoral Nerve Block (PEC I) Versus Serratus Anterior Plane Block (SAPB) for Postoperative Analgesia in Modified Radical Mastectomy
This randomized double-blind controlled clinical trial was conducted to compare the analgesic efficacy of ultrasound-guided Pectoral Nerve Block versus Serratus Anterior Plane Block in female patients undergoing Modified Radical Mastectomy. Sixty-four ASA I-II female patients aged 35-60 years were randomly allocated into two equal groups: Group I received PEC I block and Group II received SAPB, using 20 ml of 0.25% bupivacaine in both groups after induction of general anesthesia.
Postoperative pain was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters, time to first rescue analgesia, total postoperative opioid consumption, and side effects were recorded. The SAPB group showed significantly lower postoperative pain scores during the first 6 hours, significantly longer time to first rescue analgesia, and significantly lower total pethidine consumption compared to the PEC I group. In addition, mean arterial blood pressure and heart rate were significantly lower intraoperatively and during early postoperative periods in the SAPB group. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group.
Read more
Conclusion: Ultrasound-guided Serratus Anterior Plane Block provides superior postoperative analgesia with better hemodynamic stability and fewer opioid-related side effects compared to Pectoral Nerve Block in patients undergoing Modified Radical Mastectomy
modified radical mastectomy
Read the detailed description
Postoperative pain following modified radical mastectomy (MRM) is often moderate to severe and may negatively affect patient recovery, increase opioid consumption, and contribute to postoperative complications such as nausea, vomiting, and hemodynamic instability. Regional analgesic techniques have become an integral component of multimodal analgesia strategies aiming to improve pain control while minimizing opioid-related adverse effects. Among these techniques, ultrasound-guided Pectoral Nerve Block (PEC I ) and Serratus Anterior Plane Block (SAPB) have gained increasing attention for breast surgeries. This randomized double-blind controlled clinical trial was designed to compare the efficacy of ultrasound-guided PEC I block versus ultrasound-guided SAPB for postoperative analgesia in female patients undergoing modified radical mastectomy under general anesthesia.
After obtaining approval from the Research Ethics Committee of the Faculty of Medicine, Ain Shams University, and written informed consent from all participants, a total of 64 female patients aged 35-60 years with ASA physical status I or II scheduled for MRM were enrolled. Patients were randomly allocated into two equal groups (32 patients each) using a computer-generated randomization sequence with sealed opaque envelopes to ensure allocation concealment. All patients received standardized general anesthesia. Following induction of anesthesia and under complete aseptic precautions, the assigned regional block was performed using ultrasound guidance. Patients in Group I received an ultrasound-guided PEC I block, where 20 ml of 0.25% bupivacaine was injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles. Patients in Group II received an ultrasound-guided serratus anterior plane block, with 20 ml of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles. Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters including heart rate and mean arterial blood pressure were recorded intraoperatively and postoperatively at predefined intervals. The results demonstrated that SAPB provided superior postoperative analgesia compared to PEC I block. Patients in the SAPB group experienced significantly lower pain scores during the first 6 postoperative hours, a significantly longer time to first rescue analgesia, and a significant reduction in total postoperative pethidine consumption. Furthermore, the SAPB group showed better hemodynamic stability during intraoperative and early postoperative periods, with significantly lower heart rate and mean arterial blood pressure. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group. These findings suggest that ultrasound-guided serratus anterior plane block is a more effective and safer regional analgesic technique than pectoral nerve block for postoperative pain management in patients undergoing modified radical mastectomy, offering improved analgesia, reduced opioid requirements, and fewer adverse effects.
- Conditions
- Breast Cancer, Modified Radical Mastectomy, Pectoral Nerve Blocks, Serratus Anterior Plane Block
- Being tested
- Ultrasound-Guided Pectoral Nerve Block (PECS I), Ultrasound-Guided Serratus Anterior Plane Block (SAPB)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Pectoral Nerve Block (PECS I)Procedure or surgery
Participants receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia. A 20 mL solution of 0.25% bupivacaine is injected into the interpectoral plane between the pectoralis major and minor muscles. The block is performed under aseptic conditions using an in-plane needle approach from medial to lateral for postoperative analgesia following modified radical mastectomy.
Ultrasound-Guided Serratus Anterior Plane Block (SAPB)Procedure or surgery
Participants receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia. A 20 mL solution of 0.25% bupivacaine is injected between the serratus anterior muscle and the external intercostal muscles at the midaxillary line under aseptic conditions. The block is performed using an in-plane needle approach from caudal to cranial for postoperative analgesia following modified radical mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Pectoral Nerve Block (PECS I) Arm | Experimental | Participants in this arm receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles for postoperative analgesia following modified radical mastectomy. Receives: Procedure: Ultrasound-Guided Pectoral Nerve Block (PECS I) |
| Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Arm | Experimental | Participants in this arm receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles for postoperative analgesia following modified radical mastectomy. Receives: Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured by Numeric Rating Score (NRS)
Pain intensity will be assessed using the 10-point NRS at multiple time points: At the entry to the PACU, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 hours postoperatively. NRS scoring: 0 = no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10 = severe pain. The mean NRS score during the first 24 postoperative hours will serve as the primary outcome to evaluate analgesic efficacy between study groups.
Measured: Within the first 24 hours postoperatively
Secondary outcomes (5)
Time to first rescue analgesia
The duration in minutes from the end of surgery to the administration of the first rescue analgesic (Diclofenac 75 mg) will be recorded.
Measured: From the end of surgery to the administration of the first rescue analgesic.
Total pethidine consumption after surgery
The total amount of pethidine (mg) administered to each patient as rescue analgesia during the first 24 hours postoperatively will be recorded. This outcome evaluates the overall analgesic requirement and opioid-sparing effect of the blocks interventions.
Measured: Within the first 24 hours postoperatively
Mean arterial blood pressure
Mean arterial blood pressure (MAP), measured in mmHg, Measurements will be obtained at skin incision, 20min, 40 min and at 60 min intraoperatively then at at 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
Measured: Within the first 24 hours postoperatively
Heart Rate
Heart Rate (HR), measured in (Beat/minute). Measurements will be obtained at skin incision, 20min, 40 min and at 60 min intraoperatively then at at 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
Measured: From the skin incision and up to 24 hours postoperatively
Adverse events
Nausea, Vomiting
Measured: Within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start3 May 2021
- Primary completion6 Nov 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a randomized parallel-group interventional model comparing two established regional anesthesia techniques: PEC block and SAP block. Participants are randomly allocated in a 1:1 ratio using concealed assignment to ensure unbiased group distribution. Each participant receives only the technique assigned, with no crossover permitted. Standardized protocols are applied for induction, drug dosing, positioning, and monitoring to minimize procedural variability. Outcome assessors and data collectors are blinded to group allocation whenever feasible. Both groups follow identical perioperative timelines, including preoperative evaluation, intraoperative monitoring, and postoperative pain assessment. This model allows a controlled and unbiased comparison of the efficacy, safety, and clinical performance of the two techniques under uniform conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Kamal Habib, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388238
- Sponsor's protocol ID
- MS 263/ 2021
- Acronym
- PECS I vs SAP
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) from this study, including clinical parameters, and demographic information, will be shared with qualified researchers upon request after publication of the study results. Requests will be reviewed by the Principal Investigator, and approved data will be shared via a secure repository. No personal identifiers will be included to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pectoral Nerve Block (PEC I) Versus Serratus Anterior Plane Block (SAPB) for Postoperative Analgesia in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT07388238
- Acronym / sponsor ID
- PECS I vs SAP / MS 263/ 2021
- Conditions
- Breast Cancer, Modified Radical Mastectomy, Pectoral Nerve Blocks, Serratus Anterior Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 5 Feb 2026 (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 randomized double-blind controlled clinical trial was conducted to compare the analgesic efficacy of ultrasound-guided Pectoral Nerve Block versus Serratus Anterior Plane Block in female patients undergoing Modified Radical Mastectomy. Sixty-four ASA I-II female patients aged 35-60 years were randomly allocated into two equal groups: Group I received PEC I block and Group II received SAPB, using 20 ml of 0.25% bupivacaine in both groups after induction of general anesthesia.
Postoperative pain was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters, time to first rescue analgesia, total postoperative opioid consumption, and side effects were recorded. The SAPB group showed significantly lower postoperative pain scores during the first 6 hours, significantly longer time to first rescue analgesia, and significantly lower total pethidine consumption compared to the PEC I group. In addition, mean arterial blood pressure and heart rate were significantly lower intraoperatively and during early postoperative periods in the SAPB group. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group.
Conclusion: Ultrasound-guided Serratus Anterior Plane Block provides superior postoperative analgesia with better hemodynamic stability and fewer opioid-related side effects compared to Pectoral Nerve Block in patients undergoing Modified Radical Mastectomy
modified radical mastectomy
Detailed description
Postoperative pain following modified radical mastectomy (MRM) is often moderate to severe and may negatively affect patient recovery, increase opioid consumption, and contribute to postoperative complications such as nausea, vomiting, and hemodynamic instability. Regional analgesic techniques have become an integral component of multimodal analgesia strategies aiming to improve pain control while minimizing opioid-related adverse effects. Among these techniques, ultrasound-guided Pectoral Nerve Block (PEC I ) and Serratus Anterior Plane Block (SAPB) have gained increasing attention for breast surgeries. This randomized double-blind controlled clinical trial was designed to compare the efficacy of ultrasound-guided PEC I block versus ultrasound-guided SAPB for postoperative analgesia in female patients undergoing modified radical mastectomy under general anesthesia.
After obtaining approval from the Research Ethics Committee of the Faculty of Medicine, Ain Shams University, and written informed consent from all participants, a total of 64 female patients aged 35-60 years with ASA physical status I or II scheduled for MRM were enrolled. Patients were randomly allocated into two equal groups (32 patients each) using a computer-generated randomization sequence with sealed opaque envelopes to ensure allocation concealment. All patients received standardized general anesthesia. Following induction of anesthesia and under complete aseptic precautions, the assigned regional block was performed using ultrasound guidance. Patients in Group I received an ultrasound-guided PEC I block, where 20 ml of 0.25% bupivacaine was injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles. Patients in Group II received an ultrasound-guided serratus anterior plane block, with 20 ml of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles. Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters including heart rate and mean arterial blood pressure were recorded intraoperatively and postoperatively at predefined intervals. The results demonstrated that SAPB provided superior postoperative analgesia compared to PEC I block. Patients in the SAPB group experienced significantly lower pain scores during the first 6 postoperative hours, a significantly longer time to first rescue analgesia, and a significant reduction in total postoperative pethidine consumption. Furthermore, the SAPB group showed better hemodynamic stability during intraoperative and early postoperative periods, with significantly lower heart rate and mean arterial blood pressure. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group. These findings suggest that ultrasound-guided serratus anterior plane block is a more effective and safer regional analgesic technique than pectoral nerve block for postoperative pain management in patients undergoing modified radical mastectomy, offering improved analgesia, reduced opioid requirements, and fewer adverse effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study follows a randomized parallel-group interventional model comparing two established regional anesthesia techniques: PEC block and SAP block. Participants are randomly allocated in a 1:1 ratio using concealed assignment to ensure unbiased group distribution. Each participant receives only the technique assigned, with no crossover permitted. Standardized protocols are applied for induction, drug dosing, positioning, and monitoring to minimize procedural variability. Outcome assessors and data collectors are blinded to group allocation whenever feasible. Both groups follow identical perioperative timelines, including preoperative evaluation, intraoperative monitoring, and postoperative pain assessment. This model allows a controlled and unbiased comparison of the efficacy, safety, and clinical performance of the two techniques under uniform conditions.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Pectoral Nerve Block (PECS I) Arm | Experimental | Procedure: Ultrasound-Guided Pectoral Nerve Block (PECS I)Participants in this arm receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles for postoperative analgesia following modified radical mastectomy. |
| Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Arm | Experimental | Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB)Participants in this arm receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles for postoperative analgesia following modified radical mastectomy. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physical status: ASA grades I and II
- Age between 35 and 60.
Key exclusion criteria (4 listed)
- Known Allergy to one of the study drugs.
- Pregnant patients.
- Other Malignancy.
- History or evidence of coagulopathy, use of anti coagulant or anti platelet therapy
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 |
|---|---|---|
| Ultrasound-Guided Pectoral Nerve Block (PECS I)Participants receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia. A 20 mL solution of 0.25% bupivacaine is injected into the interpectoral plane between the pectoralis major and minor muscles. The block is performed under aseptic conditions using an in-plane needle approach from medial to lateral for postoperative analgesia following modified radical mastectomy. | Procedure or surgery | Ultrasound-Guided Pectoral Nerve Block (PECS I) Arm |
| Ultrasound-Guided Serratus Anterior Plane Block (SAPB)Participants receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia. A 20 mL solution of 0.25% bupivacaine is injected between the serratus anterior muscle and the external intercostal muscles at the midaxillary line under aseptic conditions. The block is performed using an in-plane needle approach from caudal to cranial for postoperative analgesia following modified radical mastectomy. | Procedure or surgery | Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Arm |
Primary outcome
Postoperative pain intensity measured by Numeric Rating Score (NRS)
Time frame: Within the first 24 hours postoperatively
Pain intensity will be assessed using the 10-point NRS at multiple time points: At the entry to the PACU, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 hours postoperatively. NRS scoring: 0 = no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10 = severe pain. The mean NRS score during the first 24 postoperative hours will serve as the primary outcome to evaluate analgesic efficacy between study groups.
5 secondary outcomes
Time to first rescue analgesia
Time frame: From the end of surgery to the administration of the first rescue analgesic.
Total pethidine consumption after surgery
Time frame: Within the first 24 hours postoperatively
Mean arterial blood pressure
Time frame: Within the first 24 hours postoperatively
Heart Rate
Time frame: From the skin incision and up to 24 hours postoperatively
Adverse events
Time frame: Within the first 24 hours postoperatively
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 5 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) from this study, including clinical parameters, and demographic information, will be shared with qualified researchers upon request after publication of the study results. Requests will be reviewed by the Principal Investigator, and approved data will be shared via a secure repository. No personal identifiers will be included to ensure participant confidentiality.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 Ultrasound-Guided Pectoral Nerve Block (PECS I) and Ultrasound-Guided Serratus Anterior Plane Block (SAPB) in people with Breast Cancer and Modified Radical Mastectomy, run by Ain Shams University 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 5 Feb 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?
Postoperative pain intensity measured by Numeric Rating Score (NRS) (time frame: Within the first 24 hours postoperatively). 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 5 Feb 2026.