Equivalent ConcentrationsNCT07872371
Different Volumes and Equivalent Concentrations of Bupivacaine in Erector Spinae Plane Block in Modified Radical Mastectomy
A study testing Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine and Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine in people with Equivalent Concentrations and Different Volumes, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to compare and evaluate the efficiency of different volumes and equivalent concentrations of bupivacaine in erector spinae plane block in reducing the Postoperative pain after modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Equivalent Concentrations, Different Volumes, Bupivacaine
- What is being tested?
- Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine and Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 31 Mar 2020
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 25-65 years.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Patients scheduled for elective unilateral modified radical mastectomy.
Who cannot join
- Patient refusal.
- Infection at the site of injection.
- Hypersensitivity to local anesthetic.
- Bleeding disorders.
- Patients with cardiac, hepatic and renal failure.
- Body mass index (BMI) ≥40 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Effects of Different Volumes and Equivalent Concentrations of Bupivacaine in Erector Spinae Plane Block in Modified Radical Mastectomy
This study aimed to compare and evaluate the efficiency of different volumes and equivalent concentrations of bupivacaine in erector spinae plane block in reducing the Postoperative pain after modified radical mastectomy.
Read the detailed description
Breast cancer is the most common cancer among women all over the world . Acute Postoperative pain is an integrated risk factor for the development of chronic post-mastectomy pain where 40% of women after breast cancer surgery will have severe acute Postoperative pain and 50% will develop chronic post-mastectomy pain with impaired quality of life.
The erector spinae plane block (ESPB) is a new technique that has been recently described in the control of chronic pain with neuropathic component of the chest wall and for pain control in thoracoscopic surgery.
- Conditions
- Equivalent Concentrations, Different Volumes, Bupivacaine, Erector Spinae Plane Block, Modified Radical Mastectomy
- Being tested
- Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine, Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaineDrug
Patients received erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine
Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaineDrug
Patients received erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received rector spinae plane block with 10 ml of 0.25% isobaric bupivacaine Receives: Drug: Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine |
| Group II | Experimental | Patients received rector spinae plane block with 20ml of 0.25% isobaric bupivacaine Receives: Drug: Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic requirements
An additional dose of 25 µg IV fentanyl was given if visual analog scale (VAS)>3.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Time of first analgesic request
Time of first analgesic request was recorded from the end of surgery till first dose of fentanyl consumption
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analogue score (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperatively
Heart rate
Heart rate was recorded from every 15 minutes till 24 hours postoperatively
Measured: 24 hours postoperatively
Mean arterial blood pressure
Mean arterial blood pressure was recorded from every 15 minutes till 24 hours postoperatively
Measured: 24 hours postoperatively
Incidence of postoperative complications
Incidence of postoperative complications like nausea, vomiting, respiratory depression, and pneumothorax 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 posted13 Oct 2026
- Study start1 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equivalent ConcentrationsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mahmoud, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872371
- Sponsor's protocol ID
- MS.18.10.314
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Effects of Different Volumes and Equivalent Concentrations of Bupivacaine in Erector Spinae Plane Block in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT07872371
- Acronym / sponsor ID
- MS.18.10.314
- Conditions
- Equivalent Concentrations, Different Volumes, Bupivacaine, Erector Spinae Plane Block, Modified Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Oct 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 study aimed to compare and evaluate the efficiency of different volumes and equivalent concentrations of bupivacaine in erector spinae plane block in reducing the Postoperative pain after modified radical mastectomy.
Detailed description
Breast cancer is the most common cancer among women all over the world . Acute Postoperative pain is an integrated risk factor for the development of chronic post-mastectomy pain where 40% of women after breast cancer surgery will have severe acute Postoperative pain and 50% will develop chronic post-mastectomy pain with impaired quality of life.
The erector spinae plane block (ESPB) is a new technique that has been recently described in the control of chronic pain with neuropathic component of the chest wall and for pain control in thoracoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Erector spinae plane block with 10 ml of 0.25% isobaric bupivacainePatients received rector spinae plane block with 10 ml of 0.25% isobaric bupivacaine |
| Group II | Experimental | Drug: Erector spinae plane block with 20 ml of 0.25% isobaric bupivacainePatients received rector spinae plane block with 20ml of 0.25% isobaric bupivacaine |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged between 25-65 years.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Patients scheduled for elective unilateral modified radical mastectomy.
Key exclusion criteria (6 listed)
- Patient refusal.
- Infection at the site of injection.
- Hypersensitivity to local anesthetic.
- Bleeding disorders.
- Patients with cardiac, hepatic and renal failure.
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 |
|---|---|---|
| Erector spinae plane block with 10 ml of 0.25% isobaric bupivacainePatients received erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine | Drug | Group I |
| Erector spinae plane block with 20 ml of 0.25% isobaric bupivacainePatients received erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine | Drug | Group II |
Primary outcome
Total analgesic requirements
Time frame: 24 hours postoperatively
An additional dose of 25 µg IV fentanyl was given if visual analog scale (VAS)>3.
5 secondary outcomes
Time of first analgesic request
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Heart rate
Time frame: 24 hours postoperatively
Mean arterial blood pressure
Time frame: 24 hours postoperatively
Incidence of postoperative complications
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 13 Oct 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.
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 Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine and Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine in people with Equivalent Concentrations and Different Volumes, run by Mansoura 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 6 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 13 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 analgesic requirements (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 13 Oct 2026.