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Evaluation of efficacy of erector spinae plane block performed with two different bupivacaine concentrations on postoperative analgesia after mastectomy surgery

Evaluation of efficacy of erector spinae plane block performed with two different bupivacaine concentrations on postoperative analgesia of adult female patients after mastectomy surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001334291
Enrollment
42
Registered
2018-08-08
Start date
2018-08-13
Completion date
2018-09-10
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our primary aim is to evaluate the efficacy of ESP block performed with two different concentrations of bupivacaine on postoperative opioid consumption after mastectomy surgery. Our hypothesis is that ESP block with higher concentration of bupivacaine will reduce postoperative opioid consumption more significantly than ESP block performed with low concentration of bupivacaine. Our secondary aims are to compare the postoperative pain scores and intraoperative fentanyl need of the groups. Our hypothesis is that ESP block performed with high concentration of bupivacaine.will reduce postoperative pain scores and fentanyl need more significantly.

Interventions

In the operating room (OR), all of the patients will receive a standard monitoring including electrocardiography, non-invasive blood pressure, peripheral oxygen saturation and bi-spectral index monitoring. After the placement of a 22-gauge intraveous line, 15 ml kg-1 isotonic saline infusion will be started. All patients will receive intravenous 0.05 midazolam for sedation. Then the patients will randomly divided into two groups based on a computerized randomization table created by a researcher

In the operating room (OR), all of the patients will receive a standard monitoring including electrocardiography, non-invasive blood pressure, peripheral oxygen saturation and bi-spectral index monitoring. After the placement of a 22-gauge intraveous line, 15 ml kg-1 isotonic saline infusion will be started. All patients will receive intravenous 0.05 midazolam for sedation. Then the patients will randomly divided into two groups based on a computerized randomization table created by a researcher who will not involve in the study. There will be two anesthesiologists in the OR. For each randomized patient, the first anesthesiologist will take the corresponding sealed envelope from a folder, which indicates the treatment assigned to the patient, while the second anesthesiologist will be blind to the group allocations. The first anesthesiologist will prepare the drug solutions for use in the study (0.25% bupivacaine or 0.375% bupivacaine solution) in two identical 20 ml syringes and a 10 ml syringe of isotonic saline for hydrodissection and pass the labeled syringes to the blinded anesthesiologist. And the patients will be placed in sitting position. In the first group (Group High ESP), the second anesthesiologist will locate the ultrasound probe in longitudinal orientation at the level of T4 spinous process and then place 3 cm laterally from the midline. The ultrasound landmarks, T4 transverse process and the overlying trapezius, rhomboideus and erector spinae muscle, will be identified. Under aseptic conditions, a 80 mm 21-gauge block needle will be inserted in-plane at an angle of 30-40 degrees in cranial-to-caudal direction until the tip contacts the T4 transverse process. After the hydrodissection with 3 mL of isotonic saline solution confirmes correct needle tip position, the anesthesiologist will inject 20 mL of 0.375% bupivacaine deep into the erector spinae muscle. The block procedure will take approximately 5-10 minutes and then the anesthesiologists will start induction of anesthesia with intravenous propofol, fentanyl and rocuronium bromide.

Sponsors

Basak ALTIPARMAK
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients with ASA physical status I-III, between 18-70 years old ,scheduled for an elective unilateral radical mastectomy with axillary lymph node dissection

Exclusion criteria

The patients with coagulation disorder, known allergy to local anesthetics, infection at the injection site, history of previous mastectomy, advanced hepatic or renal failure or chronic opioid consumption

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026