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IRCT20230410057871N12 IRCT 2026-06-17 Khoram-Abad University of Medical Sciences Evaluating the Effect of ESP Block on Postoperative Pain in Mammoplasty 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 2026-06-21 anticipated 100 Recruiting https://irct.ir/trial/90641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Macromastia (Breast Hypertrophy) / Candidates for Reduction Mammoplasty. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Once the study is complete, we will decide if it is necessary to publish the data file.
public Arian Karimi Rouzbahani
5th kilometer of Khorramabad–Borujerd Road, opposite to Kahrizak village, Lorestan University of Medical Sciences Complex, Khorramabad, Lorestan province, Iran
Khorramabad Iran (Islamic Republic of) 6814993165 +98 930 675 7977 arian.karimi@sbmu.ac.ir Khoram-Abad University of Medical Sciences scientific Siavash Beiranvand
5th kilometer of Khorramabad–Borujerd Road, opposite to Kahrizak village, Lorestan University of Medical Sciences Complex, Khorramabad , Lorestan,Iran
Khorramabad Iran (Islamic Republic of) 6814993165 +98 930 675 7977 beiranvandsiavash@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Female History of known allergy to local anesthetics (amides) Infection at the block injection site Drug or alcohol abuse Severe psychiatric disorders Treatment - Drugs Treatment - Drugs 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 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 Quality of Recovery (QoR) score. Timepoint: 24 hours postoperatively. Method of measurement: Measured using the standard 15-item Quality of Recovery (QoR-15) questionnaire. 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). Total opioid consumption. Timepoint: During the first 24 hours postoperatively. Method of measurement: Calculated and reported as Morphine Milligram Equivalents (MME). 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. Postoperative nausea and vomiting (PONV). Timepoint: During the first 24 hours postoperatively. Method of measurement: Clinical assessment and documentation of incidence. Length of hospital stay. Timepoint: At the time of patient discharge. Method of measurement: Calculated from admission to discharge in hours/days. 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). Khoram-Abad University of Medical Sciences Approved 2022-04-13 Ethics Committee of Lorestan University of Medical Sciences Moallem Street, Shahid Anushiravan Rezaei Square Khorramabad Lorestan Iran (Islamic Republic of)