An interventional study of Pectoral Nerve Block (PECS I and II) and Dexmedetomidine in Breast Cancer, sponsored by Muhammad Fiqhi Amiruddin. Completed at 1 site in Indonesia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Muhammad Fiqhi Amiruddin · Not applicable, Interventional, and Treatment
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Among 14 studies testing dexmedetomidine in Breast Neoplasms — 3 open to participants now, 3 under way, 1 of them phase 3. Dexmedetomidine · Breast Neoplasms.
Among the 14 studies testing dexmedetomidine in Breast Neoplasms, this one is the 13th largest by enrollment, is the only one that started in 2026, is one of 5 with no phase, and was the 14th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →3 of the 14 studies testing dexmedetomidine in Breast Neoplasms are open now, in 2 countries. Recruiting first, the newest first:
United States Naval Medical Center, Portsmouth · Sites in United States
Ages 18+ · Healthy volunteers
Institut Curie · Sites in France
Ages 18+ · Women only
Al-Azhar University
Ages 20–60 · Women only
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 94 across the 14 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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None of the 14 has an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Muhammad Fiqhi Amiruddin as lead sponsor.
Muhammad Fiqhi Amiruddin has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies testing dexmedetomidine in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05439005Phase 3Institut CurieOpioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study. | 2027-06-06 |
Add it to your calendar (.ics) → With an account.
Among the 14 studies testing dexmedetomidine in Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received opioid-free anesthesia combined with ultrasound-guided pectoral nerve blocks (PECS I and II).
Procedure: Pectoral Nerve Block (PECS I and II) · Drug: Dexmedetomidine
Participants received opioid-based anesthesia with fentanyl according to the study protocol.
Drug: Fentanyl
Ultrasound-guided pectoral nerve blocks (PECS I and II) performed before induction of general anesthesia.
Dexmedetomidine-based opioid-free anesthetic regimen administered according to the study protocol.
Fentanyl-based opioid anesthesia administered according to the study protocol.
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.
Time frame: Baseline to 24 hours after surgery
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.
Time frame: 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.
Time frame: Within 24 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2026 to primary completion in Jul 2026, 2 months.
Of 2,663 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 2 months is below that.
Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine