Breast CancerNCT07798895
Opioid-Free Versus Opioid-Based Anesthesia in Modified Radical Mastectomy
A study testing Pectoral Nerve Block (PECS I and II), Dexmedetomidine and Fentanyl in people with Breast Cancer, run by Muhammad Fiqhi Amiruddin at 1 site in Indonesia.
Trial summary
This randomized controlled trial compares opioid-free anesthesia combined with pectoral nerve block (PECS I and II) with opioid-based anesthesia in patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pectoral Nerve Block (PECS I and II), Dexmedetomidine and Fentanyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 May 2026to 30 Jul 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years.
- Patients undergoing modified radical mastectomy for breast cancer.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Body mass index (BMI) >18 and <30 kg/m².
- Patients who agreed to participate and provided written informed consent.
Who cannot join
- Major cardiovascular disease.
- Cerebrovascular disease.
- Hepatic or renal disease.
- Uncontrolled systemic disease.
- Previous chemotherapy or radiotherapy.
- Long-term opioid use.
Show all 11Show fewer
- Allergy to local anesthetics or opioids.
- Infection at the injection site.
- Coagulation disorders.
- Bilateral breast surgery.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Jl. Perintis Kemerdekaan Km. 10, Makassar 90245, Indonesia
Makassar, South Sulawesi, 90245
About this study
Official title: A Randomized Controlled Trial Comparing Opioid-Free Anesthesia With Pectoral Nerve Block and Opioid-Based Anesthesia in Patients Undergoing Modified Radical Mastectomy
This randomized controlled trial compares opioid-free anesthesia combined with pectoral nerve block (PECS I and II) with opioid-based anesthesia in patients undergoing modified radical mastectomy. The study evaluates postoperative CD4+ T-cell counts as a marker of cellular immune response, as well as postoperative pain intensity and nausea and vomiting. Twenty-eight patients were randomly assigned to receive either opioid-free anesthesia with PECS I and II block or opioid-based anesthesia with fentanyl. CD4+ T-cell counts were assessed before and 24 hours after surgery, while postoperative pain was assessed at 2, 6, 12, and 24 hours after surgery.
Read the detailed description
This randomized controlled trial was conducted in patients undergoing modified radical mastectomy at Wahidin Sudirohusodo General Hospital and affiliated teaching hospitals in Makassar, Indonesia. The study compared opioid-free anesthesia combined with pectoral nerve block (PECS I and II) with opioid-based anesthesia.
Twenty-eight patients were randomly allocated in a 1:1 ratio to two groups. The opioid-free anesthesia group received ultrasound-guided PECS I and II blocks before induction, followed by a dexmedetomidine-based anesthetic regimen. The opioid-based anesthesia group received a fentanyl-based anesthetic regimen. General anesthesia was maintained with sevoflurane in both groups. Randomization was performed using a computer-generated random sequence with allocation concealment using sealed, opaque envelopes. Participants and outcome assessors were blinded to group allocation.
The primary immunological outcome was the absolute CD4+ T-cell count. Venous blood samples were collected 24 hours before surgery and 24 hours after surgery, and CD4+ T-cell counts were measured using the Pima™ Alere CD4 Analyzer. Postoperative pain intensity was assessed using a 0-10 visual analogue scale at 2, 6, 12, and 24 hours after surgery, both at rest and during movement. Postoperative nausea and vomiting were assessed during the first 24 postoperative hours. Rescue analgesia with intravenous fentanyl was administered when the visual analogue scale score was 4 or higher.
The study included women aged 18-65 years undergoing modified radical mastectomy with American Society of Anesthesiologists Physical Status I-II and a body mass index greater than 18 and less than 30 kg/m². Patients with major cardiovascular, cerebrovascular, hepatic, or renal disease, uncontrolled systemic disease, previous chemotherapy or radiotherapy, long-term opioid use, allergy to local anesthetics or opioids, infection at the injection site, coagulation disorders, bilateral breast surgery, or refusal to participate were excluded.
The study was conducted from May to July 2026 and was approved by the Biomedical Research Ethics Committee, Faculty of Medicine, Hasanuddin University (approval number 979/UN4.6.4.5.31/PP36/2026). Written informed consent was obtained from all participants before participation.
- Conditions
- Breast Cancer
- Being tested
- Pectoral Nerve Block (PECS I and II), Dexmedetomidine, Fentanyl
- Keywords
- opioid-free anesthesia, opioid-based anesthesia, pectoral nerve block, PECS block, modified radical mastectomy, CD4+ T-cell, postoperative pain, postoperative nausea and vomiting
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral Nerve Block (PECS I and II)Procedure or surgery
Ultrasound-guided pectoral nerve blocks (PECS I and II) performed before induction of general anesthesia.
DexmedetomidineDrug
Dexmedetomidine-based opioid-free anesthetic regimen administered according to the study protocol.
FentanylDrug
Fentanyl-based opioid anesthesia administered according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia + PECS I and II Block | Experimental | Participants received opioid-free anesthesia combined with ultrasound-guided pectoral nerve blocks (PECS I and II). Receives: Procedure: Pectoral Nerve Block (PECS I and II); Drug: Dexmedetomidine |
| Opioid-Based Anesthesia | Active comparator | Participants received opioid-based anesthesia with fentanyl according to the study protocol. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Absolute CD4+ T-Cell Count From Baseline to 24 Hours After Surgery
Change in absolute CD4+ T-cell count measured from baseline before surgery to 24 hours after surgery. CD4+ T-cell counts were measured using the Pima™ Alere CD4 Analyzer.
Measured: Baseline to 24 hours after surgery
Secondary outcomes (2)
Postoperative Pain Intensity
Postoperative pain intensity was assessed using a visual analogue scale (VAS) from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed at rest and during movement.
Measured: 2, 6, 12, and 24 hours after surgery
Postoperative Nausea and Vomiting
Postoperative nausea and vomiting were assessed during the first 24 hours after surgery.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start3 May 2026
- Primary completion27 Jul 2026
- Study completion30 Jul 2026
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.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either opioid-free anesthesia combined with PECS I and II block or opioid-based anesthesia. Each participant received the assigned intervention throughout the perioperative period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Fiqhi Amiruddin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Fiqhi Amiruddin, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798895
- Sponsor's protocol ID
- OFA-PECS-MRM-2026
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Opioid-Free Anesthesia With Pectoral Nerve Block and Opioid-Based Anesthesia in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT07798895
- Acronym / sponsor ID
- OFA-PECS-MRM-2026
- Conditions
- Breast Cancer
- Keywords
- opioid-free anesthesia, opioid-based anesthesia, pectoral nerve block, PECS block, modified radical mastectomy, CD4+ T-cell, postoperative pain, postoperative nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Muhammad Fiqhi AmiruddinUniversity, hospital or other
- Study start
- 3 May 2026 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 2 Sep 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 controlled trial compares opioid-free anesthesia combined with pectoral nerve block (PECS I and II) with opioid-based anesthesia in patients undergoing modified radical mastectomy. The study evaluates postoperative CD4+ T-cell counts as a marker of cellular immune response, as well as postoperative pain intensity and nausea and vomiting. Twenty-eight patients were randomly assigned to receive either opioid-free anesthesia with PECS I and II block or opioid-based anesthesia with fentanyl. CD4+ T-cell counts were assessed before and 24 hours after surgery, while postoperative pain was assessed at 2, 6, 12, and 24 hours after surgery.
Detailed description
This randomized controlled trial was conducted in patients undergoing modified radical mastectomy at Wahidin Sudirohusodo General Hospital and affiliated teaching hospitals in Makassar, Indonesia. The study compared opioid-free anesthesia combined with pectoral nerve block (PECS I and II) with opioid-based anesthesia.
Twenty-eight patients were randomly allocated in a 1:1 ratio to two groups. The opioid-free anesthesia group received ultrasound-guided PECS I and II blocks before induction, followed by a dexmedetomidine-based anesthetic regimen. The opioid-based anesthesia group received a fentanyl-based anesthetic regimen. General anesthesia was maintained with sevoflurane in both groups. Randomization was performed using a computer-generated random sequence with allocation concealment using sealed, opaque envelopes. Participants and outcome assessors were blinded to group allocation.
The primary immunological outcome was the absolute CD4+ T-cell count. Venous blood samples were collected 24 hours before surgery and 24 hours after surgery, and CD4+ T-cell counts were measured using the Pima™ Alere CD4 Analyzer. Postoperative pain intensity was assessed using a 0-10 visual analogue scale at 2, 6, 12, and 24 hours after surgery, both at rest and during movement. Postoperative nausea and vomiting were assessed during the first 24 postoperative hours. Rescue analgesia with intravenous fentanyl was administered when the visual analogue scale score was 4 or higher.
The study included women aged 18-65 years undergoing modified radical mastectomy with American Society of Anesthesiologists Physical Status I-II and a body mass index greater than 18 and less than 30 kg/m². Patients with major cardiovascular, cerebrovascular, hepatic, or renal disease, uncontrolled systemic disease, previous chemotherapy or radiotherapy, long-term opioid use, allergy to local anesthetics or opioids, infection at the injection site, coagulation disorders, bilateral breast surgery, or refusal to participate were excluded.
The study was conducted from May to July 2026 and was approved by the Biomedical Research Ethics Committee, Faculty of Medicine, Hasanuddin University (approval number 979/UN4.6.4.5.31/PP36/2026). Written informed consent was obtained from all participants before participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either opioid-free anesthesia combined with PECS I and II block or opioid-based anesthesia. Each participant received the assigned intervention throughout the perioperative period.
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia + PECS I and II Block | Experimental | Procedure: Pectoral Nerve Block (PECS I and II), Drug: DexmedetomidineParticipants received opioid-free anesthesia combined with ultrasound-guided pectoral nerve blocks (PECS I and II). |
| Opioid-Based Anesthesia | Active comparator | Drug: FentanylParticipants received opioid-based anesthesia with fentanyl according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18-65 years.
- Patients undergoing modified radical mastectomy for breast cancer.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Body mass index (BMI) >18 and <30 kg/m².
- Patients who agreed to participate and provided written informed consent.
Key exclusion criteria (11 listed)
- Major cardiovascular disease.
- Cerebrovascular disease.
- Hepatic or renal disease.
- Uncontrolled systemic disease.
- Previous chemotherapy or radiotherapy.
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 |
|---|---|---|
| Pectoral Nerve Block (PECS I and II)Ultrasound-guided pectoral nerve blocks (PECS I and II) performed before induction of general anesthesia. | Procedure or surgery | Opioid-Free Anesthesia + PECS I and II Block |
| DexmedetomidineDexmedetomidine-based opioid-free anesthetic regimen administered according to the study protocol. | Drug | Opioid-Free Anesthesia + PECS I and II Block |
| FentanylFentanyl-based opioid anesthesia administered according to the study protocol. | Drug | Opioid-Based Anesthesia |
Primary outcome
Change in Absolute CD4+ T-Cell Count From Baseline to 24 Hours After Surgery
Time frame: Baseline to 24 hours after surgery
Change in absolute CD4+ T-cell count measured from baseline before surgery to 24 hours after surgery. CD4+ T-cell counts were measured using the Pima™ Alere CD4 Analyzer.
2 secondary outcomes
Postoperative Pain Intensity
Time frame: 2, 6, 12, and 24 hours after surgery
Postoperative Nausea and Vomiting
Time frame: Within 24 hours after surgery
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 2 Sep 2026.
- 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 Pectoral Nerve Block (PECS I and II), Dexmedetomidine and Fentanyl in people with Breast Cancer, run by Muhammad Fiqhi Amiruddin at 1 site in Indonesia.
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 5 inclusion and 11 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 2 Sep 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 Indonesia. 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?
Change in Absolute CD4+ T-Cell Count From Baseline to 24 Hours After Surgery (time frame: Baseline to 24 hours after surgery). 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 2 Sep 2026.