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Nerve BlockNCT07001657

Pectoral Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Breast Cancer Surgery

A study testing SPSIP Block and PECS II Block in people with Nerve Block, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Pectoral Nerve Block (PECS II) and the Serratus Posterior Superior Intercostal Plane (SPSIP) Block in patients undergoing breast cancer surgery. The primary outcome is total opioid consumption in the first 24 hours. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Nerve Block
What is being tested?
SPSIP Block and PECS II Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 May 2025to 27 Jan 2026
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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body Mass Index (BMI) less than 35 kg/m²
  • Unilateral breast cancer surgery

Who cannot join

  • Patient refusal to participate
  • BMI greater than or equal to 35 kg/m²
  • ASA physical status IV-V
  • Known allergy to any study medications
  • Pregnancy or breastfeeding
  • Presence of neuromuscular diseases
Show all 11Show fewer
  • Chronic opioid use
  • Chronic pain syndromes
  • Significant organ failure (e.g., cardiac, hepatic, renal)
  • Contraindications to regional nerve blocks
  • Bilateral breast surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Antalya Training and Research Hospital

    Antalya, 07010

Other trials in Turkey (Türkiye)

About this study

Official title: Analgesic Efficacy of Pectoral Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Breast Cancer Surgery; Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Pectoral Nerve Block (PECS II) and the Serratus Posterior Superior Intercostal Plane (SPSIP) Block in patients undergoing breast cancer surgery. The primary outcome is total opioid consumption in the first 24 hours. Secondary outcomes include pain scores (VAS), block performance time, number of needle passes, postoperative recovery quality (QoR-15), time to first analgesic request, and complications (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection).

Read the detailed description

Study Objective This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Pectoral Nerve Block (PECS II) and Serratus Posterior Superior Intercostal Plane Block (SPSIP) on total opioid consumption within the first 24 hours and on Visual Analog Scale (VAS) scores in patients undergoing breast cancer surgery. Secondary outcomes include evaluating the impact of these blocks on intraoperative opioid requirement and postoperative recovery quality.

Materials and Methods This prospective, randomized clinical study will include voluntary female patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) <35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.

Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.

Study Groups and Block Procedures Group SPSIP will receive a unilateral SPSIP block, and Group PECS-II will receive a unilateral PECS II block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.

SPSIP Block:

The Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of the scapula at the level of the second and third ribs on the surgical side.

Anatomical landmarks, including the trapezius, rhomboid major muscle (RMM), serratus posterior superior muscle (SPSM), and the second and third ribs will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be inserted into the fascial plane between the third rib and the SPSM. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 30 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered.

The block performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.

PECS II Block:

Patients will be placed in the supine position, and the PECS II block will be administered. Prior to all blocks, the skin will be disinfected with chlorhexidine, and the skin and subcutaneous tissue will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be used and positioned at the level of the third and fourth ribs along the mid-axillary line on the surgical side.

Key anatomical landmarks including the pectoralis major, pectoralis minor, and serratus anterior muscles, as well as the third and fourth ribs will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be advanced into the fascial plane between the pectoralis minor and serratus anterior muscles. Proper needle placement will be confirmed by the injection of 1-2 mL of isotonic saline, followed by the administration of 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey).

The needle will then be redirected to the fascial plane between the pectoralis major and pectoralis minor muscles. Following negative aspiration and confirmation of correct positioning with 1-2 mL of isotonic saline, 10 mL of 0.25% bupivacaine will be injected.

The block performance time defined as the time interval from the ultrasound probe's contact with the skin to the withdrawal of the needle after the final injection will be recorded.

General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).

Anesthesia maintenance will be provided using 2% sevoflurane in a 50% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO₂ maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.

Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 0.15 mg/kg of intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU).

Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.

Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 1, 3, 6, 12, and 24 hours postoperatively. All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours. Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.

Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.

Patient and Surgeon Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.

Nausea and Vomiting

Nausea and vomiting will be scored using a 4-point scale:

0 = none

  1. = mild
  2. = moderate
  3. = severe

Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, or infection) will be recorded.

Length of Hospital Stay The duration from the end of surgery to hospital discharge will be recorded.

Conditions
Nerve Block
Being tested
SPSIP Block, PECS II Block
Keywords
pectoral nerve block, Breast Cancer Surgery, Serratus Posterior Superior Intercostal Plane Block, Postoperative Pain, Patient Controlled Analgesia
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPSIP BlockProcedure or surgery

    Patients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.

  • PECS II BlockProcedure or surgery

    Patients in this group will receive an ultrasound-guided PECS II block with 30 mL of 0.25% bupivacaine hydrochloride (20 mL between the pectoralis minor and serratus anterior muscles, and 10 mL between the pectoralis major and minor muscles), 30 minutes before breast cancer surgery.

Study groups in NCT07001657
Study groupRoleWhat they receive
SPSIP BlockActive comparatorPatients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.
Receives: Procedure: SPSIP Block
PECS II BlockActive comparatorPatients in this group will receive an ultrasound-guided PECS II block with 30 mL of 0.25% bupivacaine hydrochloride (20 mL between the pectoralis minor and serratus anterior muscles, and 10 mL between the pectoralis major and minor muscles), 30 minutes before breast cancer surgery.
Receives: Procedure: PECS II Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total opioid consumption

    Total opioid consumption (mg) in the first 24 hours postoperatively, measured using a PCA device.

    Measured: the first 24 hours postoperatively

Secondary outcomes (7)
  1. Postoperative Visual Analog Scale (VAS) Scores - Static and Dynamic Pain

    Pain intensity will be evaluated using the Visual Analog Scale (VAS) at rest (static) and during movement (dynamic) at postoperative hours 1, 3, 6, 12, and 24. The VAS is scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating worse pain.

    Measured: 1, 3, 6, 12, and 24 hours postoperatively.

  2. Block performance time

    Time from ultrasound probe-skin contact to needle withdrawal after injection.

    Measured: During the procedure (from ultrasound probe-skin contact until needle withdrawal, assessed preoperatively)

  3. Number of needle passes

    Number of times the needle trajectory was changed after skin entry without full withdrawal.

    Measured: During the procedure (number of times the needle trajectory was changed without full withdrawal after skin entry, assessed preoperatively)

  4. Quality of recovery assessed by the QoR-15 scale.

    Quality of recovery will be assessed using the QoR-15 scale (range: 0-150), where higher scores indicate better recovery.

    Measured: 24 hours postoperatively.

  5. Time to first analgesic request.

    The duration from patient enrollment to the first request for pain relief.

    Measured: Within 24 hours postoperatively

  6. Patient and surgeon satisfaction (5-point Likert scale).

    Satisfaction will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied)

    Measured: 24 hours postoperatively

  7. intraoperative opioid consumption

    Intraoperative opioids consumption (remifentanyl measured as mcg/kg)

    Measured: During the surgery(From patient intubation to patient extubation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start25 May 2025
  3. Primary completion1 Dec 2025
  4. Study completion27 Jan 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001657
Sponsor's protocol ID
AEAHYE001
Status last verified
Jan 2026
First submitted
16 May 2025
Last updated
28 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SPSIP Block and PECS II Block in people with Nerve Block, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

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 4 inclusion and 11 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 28 Jan 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 Turkey (Türkiye). 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 opioid consumption (time frame: the first 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 28 Jan 2026.

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