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Evaluation of Ultrasound-Guided Bilateral Erector Spinae Plane (ESP) Block Combined with Tumescent Anesthesia Versus Tumescent Anesthesia Alone for Postoperative Analgesia in Mammoplasty Candidates: A Clinical Trial

Protocol summary

Study aim
Investigating the Effect of Ultrasound-Guided Bilateral Erector Spinae Plane Block on Quality of Recovery in Candidates for Reduction Mammoplasty
Design
A randomized, double-blind, parallel-group, controlled clinical trial on 100 patients(50 patients in each group).Randomization was performed using a random number table generated by the org.Randomizer software with a 1:1 allocation ratio.
Settings and conduct
This randomized, double-blind clinical trial is being conducted on women who undergo reduction mammoplasty at Shohada Ashayer hospital. Patients will be randomly assigned (with concealment via opaque, sealed envelopes) to two groups: intervention group and control group.In this study, surgeon and outcome expectations are independent of the groupings.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Women aged 18 to 65 years, candidates for elective reduction mammoplasty, with a Body Mass Index of 18 to 35, who have provided informed consent. Exclusion Criteria:Inability to understand the questionnaire, inability to use Patient-Controlled Analgesia, allergy to local anesthetics (amides), coagulation disorders, history of breast or thoracic spine surgery,substance abuse, and severe psychiatric disorders.
Intervention groups
Both groups receive general anesthesia and tumescent solution. The intervention group receives an ultrasound-guided bilateral ESP block (60 ml of 0.25% levobupivacaine at T5), while the control group receives a sham subcutaneous saline injection.
Main outcome variables
Primary Outcome: Quality of recovery 24 hours post-surgery, assessed using the QoR-15 questionnaire. Secondary Outcomes: Total opioid consumption (MME) in the first 24 hours; pain severity (NRS) from 30 minutes to 24 hours post-operatively; time to first analgesic request; incidence of post-operative nausea and vomiting (PONV); duration of hospital stay; and adverse events.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230410057871N12
Registration date: 2026-06-17, 1405/03/27
Registration timing: prospective

Last update: 2026-06-17, 1405/03/27
Update count: 0
Registration date
2026-06-17, 1405/03/27
Registrant information
Name
Arian Karimi Rouzbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3324 1229
Email address
arian.karimi@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-21, 1405/03/31
Expected recruitment end date
2026-08-22, 1405/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ultrasound-Guided Bilateral Erector Spinae Plane (ESP) Block Combined with Tumescent Anesthesia Versus Tumescent Anesthesia Alone for Postoperative Analgesia in Mammoplasty Candidates: A Clinical Trial
Public title
Evaluating the Effect of ESP Block on Postoperative Pain in Mammoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients aged 18 to 65 years Candidates for elective reduction mammoplasty Body Mass Index (BMI) between 18 and 35 kg/m² American Society of Anesthesiologists (ASA) physical status class I or II
Exclusion criteria:
History of known allergy to local anesthetics (amides) Infection at the block injection site Drug or alcohol abuse Severe psychiatric disorders
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated randomization using an online random number generator (Randomizer.org) with a 1:1 allocation ratio. To ensure allocation concealment, the randomization sequence will be generated by a statistician and concealed in sequentially numbered, opaque, sealed envelopes. The envelopes will be opened by the anesthesiologist only after the induction of general anesthesia.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomized, Double-blind trial. The patient, the operating surgeon, and the outcome assessor (evaluating pain and quality of recovery) will be completely blinded to the group allocations. To preserve patient blinding, the block intervention is strictly performed after the induction of general anesthesia.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Moallem Street, Shahid Anushiravan Rezaei Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.LUMS.REC.1404.369

Health conditions studied

1

Description of health condition studied
Macromastia (Breast Hypertrophy) / Candidates for Reduction Mammoplasty
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of Recovery (QoR) score
Timepoint
24 hours postoperatively
Method of measurement
Measured using the standard 15-item Quality of Recovery (QoR-15) questionnaire

Secondary outcomes

1

Description
Postoperative pain intensity
Timepoint
At 30 minutes, 1, 2, 4, 6, 12, and 24 hours postoperatively
Method of measurement
Measured using the Numeric Rating Scale (NRS - score 0 to 10)

2

Description
Total opioid consumption
Timepoint
During the first 24 hours postoperatively
Method of measurement
Calculated and reported as Morphine Milligram Equivalents (MME)

3

Description
Time to first analgesic request
Timepoint
From the end of surgery until the patient’s first request for analgesia
Method of measurement
Exact time recorded in minutes/hours by the assessor

4

Description
Postoperative nausea and vomiting (PONV)
Timepoint
During the first 24 hours postoperatively
Method of measurement
Clinical assessment and documentation of incidence

5

Description
Length of hospital stay
Timepoint
At the time of patient discharge
Method of measurement
Calculated from admission to discharge in hours/days

6

Description
Adverse effects / Complications
Timepoint
During hospitalization and up to 24 hours postoperatively
Method of measurement
Clinical examination and documentation of any complications (e.g., local anesthetic toxicity, infection, hematoma)

Intervention groups

1

Description
Intervention group:In the intervention group, following the induction of general anesthesia and prior to the commencement of surgery, a bilateral Erector Spinae Plane (ESP) block is performed under sterile conditions. Using an ultrasound machine equipped with a linear probe, the transverse process of the fifth thoracic vertebra (T5) is identified. A 22-gauge echogenic needle is then inserted using an in-plane technique into the fascial plane between the erector spinae muscle and the transverse process. After confirming the correct needle placement by injecting 1 to 2 mL of normal saline, 0.25% levobupivacaine (manufactured by [sina pishgam daroo novin]) is injected. The administered dose is 30 mL on each side (a total of 60 mL). This intervention is performed only once as a single dose prior to the surgery
Category
Treatment - Drugs

2

Description
Control group:In the control group, patients undergo reduction mammoplasty following the induction of standard general anesthesia (identical to the intervention group). To maintain the blinding of the study for both the patient and the outcome assessor, a sham injection (subcutaneous normal saline) is administered instead of a local anesthetic. For this purpose, 0.9% normal saline (manufactured by [shahid ghazi]) is used. The injection volume is 30 mL on each side (a total of 60 mL), administered as a single dose just once prior to the surgical incision. Additionally, similar to the intervention group, a standard tumescent solution is injected into the surgical site by the surgeon. In this group, no injections are performed in the paravertebral area or the Erector Spinae Plane, and patients only receive general anesthesia, a subcutaneous sham injection, and surgical tumescent infiltration
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Ashayer Hospital
Full name of responsible person
Arian Karimi Rouzbahani
Street address
Enghelab street
City
Khorramabad
Province
Lorestan
Postal code
6816933133
Phone
+98 66 3323 6401
Email
shohadahospital@lums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Peyman Astaraki
Street address
Khorramabad, Kamalvand, Km 4 Khorramabad–Borujerd Road, Pardis Academic Complex, Lorestan University of Medical Sciences, Deputy of Research and Technology
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 0333 1660
Email
peymanastaraki@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arian Karimi Rouzbahani
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
5th kilometer of Khorramabad–Borujerd Road, opposite to Kahrizak village, Lorestan University of Medical Sciences Complex, Khorramabad, Lorestan province, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 930 675 7977
Email
arian.karimi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Siavash Beiranvand
Position
Medical doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5th kilometer of Khorramabad–Borujerd Road, opposite to Kahrizak village, Lorestan University of Medical Sciences Complex, Khorramabad , Lorestan,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 930 675 7977
Email
beiranvandsiavash@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arian Karimi Rouzbahani
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
5th kilometer of Khorramabad–Borujerd Road, opposite to Kahrizak village, Lorestan University of Medical Sciences Complex, Khorramabad , Lorestan,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 930 675 7977
Email
arian.karimi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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