Opioid Free AnesthesiaNCT07913789
Opioid Free Anesthesia Combined With Pectoral Nerve Block (PECS Block) in Breast Cancer Surgery
A study testing Opioid Free Anesthesia and Opioid based anesthesia in people with Opioid Free Anesthesia and Pectoral Nerve Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of opioid free anesthesia combined with pectoral Nerve Block (PECS block) in patients undergoing breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Free Anesthesia, Pectoral Nerve Block, Breast Cancer Surgery
- What is being tested?
- Opioid Free Anesthesia and Opioid based anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Oct 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled unilateral breast cancer surgery.
Who cannot join
- Patient refusal to participate in the study
- Psychiatric disorder, communication difficulties and chronic neurological disease.
- History of allergy to local anesthetics.
- Patients with bleeding disorders, on anticoagulants or with skin infection at the site of injection.
- Patients with pre-existing severe major organ dysfunction such as cardiac, hepatic, renal impairment.
- Body Mass Index (BMI) ≥ 35 kg/m2.
- Chest wall deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anesthesia Combined With Pectoral Nerve Block (PECS Block) in Breast Cancer Surgery: A Prospective Randomized Study
The aim of this study is to evaluate the efficacy of opioid free anesthesia combined with pectoral Nerve Block (PECS block) in patients undergoing breast cancer surgery.
Read the detailed description
Breast cancer is the most commonly diagnosed neoplasm in women and accounts for nearly a third (29%) of all malignancies, representing the leading cause of cancer death among women worldwide.
Pectoralis Nerve Block (PECS), is an ultrasound-guided regional anesthesia technique used to block the nerves of the chest wall, providing analgesia for breast surgery and other anterior chest wall procedures.
- Being tested
- Opioid Free Anesthesia, Opioid based anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free AnesthesiaProcedure or surgery
Patients received ultrasound-guided pectoral nerve block (PECS) using 30 mL of 0.25% bupivacaine after induction of anesthesia. General Anesthesia was induced in an opioid-free manner.
Opioid based anesthesiaProcedure or surgery
Patients received conventional general anesthesia with intraoperative opioids as per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Free Anesthesia Group | Experimental | Patients received ultrasound-guided pectoral nerve block (PECS) using 30 mL of 0.25% bupivacaine after induction of anesthesia. General Anesthesia was induced in an opioid-free manner. Receives: Procedure: Opioid Free Anesthesia |
| Opioid based anesthesia Control Group | Active comparator | Patients received conventional general anesthesia with intraoperative opioids as per institutional protocol. Receives: Procedure: Opioid based anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
For each patient with [Visual Analogue Scale (VAS) > 4], 3 mg of morphine will be prescribed as rescue analgesia to be repeated after 30 min if pain persists until the VAS< 4.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Heart rate
Heart rate was recorded at baseline, after performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Mean arterial blood pressure
Mean arterial blood pressure was recorded at baseline, after performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Degree of pain
All the participants were explained about postoperative pain assessment with the visual analogue scale (VAS), from 0 to 10 (0 represents "no pain" while 10 represents "the worst pain imaginable")
Measured: 24 hours postoperatively
Time to extubation
The time to extubate was counted starting from stoppage of inhalational anesthetic agent till the extubating was practiced.
Measured: Till the extubating (Up to 60 minutes)
Quality of recovery
Quality of recovery was assessed using Modified Aldrete Score (depending on conscious level, activity of the patient, breathing, blood pressure, oxygen saturation).
Measured: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia was recorded from end of surgery to first dose of morphine administrated.
Measured: 24 hours postoperatively
Incidence of side effects
Incidence of side effects such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hematoma at the site of injection, and local anesthetic toxicity were recorded.
Measured: 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 posted3 Nov 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Eloraby Eloraby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913789
- Sponsor's protocol ID
- 36264MS10102/10/25
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia Combined With Pectoral Nerve Block (PECS Block) in Breast Cancer Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07913789
- Acronym / sponsor ID
- 36264MS10102/10/25
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 3 Nov 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.
The aim of this study is to evaluate the efficacy of opioid free anesthesia combined with pectoral Nerve Block (PECS block) in patients undergoing breast cancer surgery.
Detailed description
Breast cancer is the most commonly diagnosed neoplasm in women and accounts for nearly a third (29%) of all malignancies, representing the leading cause of cancer death among women worldwide.
Pectoralis Nerve Block (PECS), is an ultrasound-guided regional anesthesia technique used to block the nerves of the chest wall, providing analgesia for breast surgery and other anterior chest wall procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Free Anesthesia Group | Experimental | Procedure: Opioid Free AnesthesiaPatients received ultrasound-guided pectoral nerve block (PECS) using 30 mL of 0.25% bupivacaine after induction of anesthesia. General Anesthesia was induced in an opioid-free manner. |
| Opioid based anesthesia Control Group | Active comparator | Procedure: Opioid based anesthesiaPatients received conventional general anesthesia with intraoperative opioids as per institutional protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled unilateral breast cancer surgery.
Key exclusion criteria (7 listed)
- Patient refusal to participate in the study
- Psychiatric disorder, communication difficulties and chronic neurological disease.
- History of allergy to local anesthetics.
- Patients with bleeding disorders, on anticoagulants or with skin infection at the site of injection.
- Patients with pre-existing severe major organ dysfunction such as cardiac, hepatic, renal impairment.
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 |
|---|---|---|
| Opioid Free AnesthesiaPatients received ultrasound-guided pectoral nerve block (PECS) using 30 mL of 0.25% bupivacaine after induction of anesthesia. General Anesthesia was induced in an opioid-free manner. | Procedure or surgery | Opioid Free Anesthesia Group |
| Opioid based anesthesiaPatients received conventional general anesthesia with intraoperative opioids as per institutional protocol. | Procedure or surgery | Opioid based anesthesia Control Group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
For each patient with [Visual Analogue Scale (VAS) > 4], 3 mg of morphine will be prescribed as rescue analgesia to be repeated after 30 min if pain persists until the VAS< 4.
7 secondary outcomes
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Mean arterial blood pressure
Time frame: Till the end of surgery (Up to 2 hours)
Degree of pain
Time frame: 24 hours postoperatively
Time to extubation
Time frame: Till the extubating (Up to 60 minutes)
Quality of recovery
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Incidence of side effects
Time frame: 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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Opioid Free Anesthesia and Opioid based anesthesia in people with Opioid Free Anesthesia and Pectoral Nerve Block, run by Tanta 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 3 inclusion and 7 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 3 Nov 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 morphine consumption (time frame: 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 3 Nov 2026.