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CompletedNCT07872371Updated Oct 13, 2026

Different Volumes and Equivalent Concentrations of Bupivacaine in Erector Spinae Plane Block in Modified Radical Mastectomy

An interventional study of 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 Equivalent Concentrations, Different Volumes and Bupivacaine, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years after the study started (first participant enrolled Oct 2019, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Equivalent Concentrations
  • Different Volumes
  • Bupivacaine
  • Erector Spinae Plane Block
  • Modified Radical Mastectomy
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group I

    Patients received rector spinae plane block with 10 ml of 0.25% isobaric bupivacaine

    Drug: Erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine

  • Experimental
    Group II

    Patients received rector spinae plane block with 20ml of 0.25% isobaric bupivacaine

    Drug: Erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine

Interventions

  • DrugErector spinae plane block with 10 ml of 0.25% isobaric bupivacaine

    Patients received erector spinae plane block with 10 ml of 0.25% isobaric bupivacaine

  • DrugErector spinae plane block with 20 ml of 0.25% isobaric bupivacaine

    Patients received erector spinae plane block with 20 ml of 0.25% isobaric bupivacaine

06

What researchers measure

Primary outcomes

  1. Total analgesic requirements

    An additional dose of 25 µg IV fentanyl was given if visual analog scale (VAS)\>3.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Time of first analgesic request

    Time of first analgesic request was recorded from the end of surgery till first dose of fentanyl consumption

    Time frame: 24 hours postoperatively

  2. 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").

    Time frame: 24 hours postoperatively

  3. Heart rate

    Heart rate was recorded from every 15 minutes till 24 hours postoperatively

    Time frame: 24 hours postoperatively

  4. Mean arterial blood pressure

    Mean arterial blood pressure was recorded from every 15 minutes till 24 hours postoperatively

    Time frame: 24 hours postoperatively

  5. Incidence of postoperative complications

    Incidence of postoperative complications like nausea, vomiting, respiratory depression, and pneumothorax were recorded.

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Mansoura University
    Al Mansurah, 35516, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07872371
Responsible party
Mai Mahmoud (Lecturer of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt, Mansoura University) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 1, 2019
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Oct 13, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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