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AnalgesiaNCT06936852

Ultrasound Guided Serratus Posterior Superior Intercostal Plane Versus PECS II Block In Breast Surgeries

A study testing Serratus posterior superior intercostal plane block and PECS II block in people with Analgesia, run by Tanta University at 1 site in Egypt.

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

The aim of the study is to compare the analgesic effect of ultrasound guided serratus posterior superior intercostal plane (SPSIP) block and pectoral nerve (PECS II) block in different breast surgeries. Read more about this study

Who is it for?
Ages 21 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Analgesia
What is being tested?
Serratus posterior superior intercostal plane block and PECS II block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
27 Feb 2025to 27 Mar 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 21 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age from 21 to 70 years.
  • American Society of Anesthesiologists (ASA) Physical Status Classification System I-II.

Who cannot join

  • Any patient refuses to participate.
  • Bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases.
  • Chronic opioid use.
  • Patients with pulmonary diseases.
  • History of allergy to local anesthetics.
  • Infection at the needle entry point will be excluded.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University

    Tanta, Select, 1234

Other trials in Egypt

About this study

Official title: Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Pectoral Nerve (PECS II) Block For Pain Control In Breast Surgeries: A Randomized Comparative Trial

The aim of the study is to compare the analgesic effect of ultrasound guided serratus posterior superior intercostal plane (SPSIP) block and pectoral nerve (PECS II) block in different breast surgeries.

Read the detailed description

All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Standard basic monitoring will be applied to all patients then after adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.

SPSIP group After induction of anesthesia, patients will be placed in lateral decubitus position, the affected arm will be adducted and medially rotated. Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The structures from superficial to deep are skin, subcutaneous, trapezius, rhomboid, serratus posterior superior and intercostal muscles. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.

PECS II group With the patient in supine position, the ipsilateral upper arm will be abducted and externally rotated. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.

After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed. Intravenous 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.

Conditions
Analgesia
Being tested
Serratus posterior superior intercostal plane block, PECS II block
Keywords
serratus posterior superior, pecs, breast surgery
Medical subject headings
Agnosia

What participants receive

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

  • Serratus posterior superior intercostal plane blockProcedure or surgery

    Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.

  • PECS II blockProcedure or surgery

    . Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.

Study groups in NCT06936852
Study groupRoleWhat they receive
SPSIP GroupActive comparatorUnder complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
Receives: Procedure: Serratus posterior superior intercostal plane block
PECS II groupActive comparatorUnder complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
Receives: Procedure: PECS II block

What is being measured

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

  1. Total morphine consumption

    Total morphine consumption in first postoperative twenty four hour

    Measured: first postoperative 24 hour

  2. Bedside forced vital capacity at 2 hours after surgery

    Three measurements were taken and the highest one was recorded

    Measured: Two hours after surgery

Secondary outcomes (7)
  1. NRS pain scores for breast and axilla when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement

    NRS when reaching recovery room, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour

    Measured: when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour

  2. Time to first rescue opioid dose

    Morphine given for pain scores more than or equal to 4

    Measured: 24 hours after surgery

  3. Incidence of chronic pain at 3 and 6 months after surgery

    Any pain with score more than 3 is considered positive for chronic pain

    Measured: 6 months after surgery

  4. Block related complications and side effects

    Vomiting, bradycardia, hypotension, and pneumothorax will be recorded

    Measured: 24 hours after surgery

  5. Bedside forced vital capacity at 6 and 24 hours after surgery

    Three measurements were taken and the highest one was recorded

    Measured: 24 hours after surgery

  6. Additional intraoperative fentanyl consumption

    Additional intraoperative fentanyl consumption which not used during induction

    Measured: during surgery

  7. Heart rate and mean arterial blood pressure

    • Heart rate and mean arterial blood pressure

    Measured: baseline and during surgery

Timeline

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

  1. First posted20 Apr 2025
  2. Study start27 Feb 2025
  3. Primary completion27 Sep 2025
  4. Study completion27 Mar 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06936852
Sponsor's protocol ID
36264PR1097/2/25
Status last verified
Apr 2026
First submitted
30 Mar 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Gundogdu O, Avci O, Balci F, Tekcan MN, Kol YC. Efficacy of Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: An Evidence Based Report. J Coll Physicians Surg Pak. 2024 Mar;34(3):348-350. doi: 10.29271/jcpsp.2024.03.348.

    PubMed 38462873

Questions about this trial

What is this clinical trial studying?

A study testing Serratus posterior superior intercostal plane block and PECS II block in people with Analgesia, run by Tanta University at 1 site in Egypt.

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 2 inclusion and 6 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 3 Jun 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 Egypt. 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 morphine consumption (time frame: first postoperative 24 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06936852, which also lists 1 linked publication.

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 3 Jun 2026.

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