NCT06936852

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 30, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

March 30, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

serratus posterior superiorpecsbreast surgery

Outcome Measures

Primary Outcomes (2)

  • Total morphine consumption

    Total morphine consumption in first postoperative twenty four hour

    first postoperative 24 hour

  • Bedside forced vital capacity at 2 hours after surgery

    Three measurements were taken and the highest one was recorded

    Two hours after surgery

Secondary Outcomes (6)

  • NRS pain scores for breast when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement

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

  • Time to first rescue opioid dose

    24 hours after surgery

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

    6 months after surgery

  • Block related complications and side effects

    24 hours after surgery

  • Axilla NRS pain scores evaluated at the same time points of that for breast pain

    24 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

SPSIP Group

ACTIVE COMPARATOR

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.

Procedure: Serratus posterior superior intercostal plane block

PECS II group

ACTIVE COMPARATOR

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.

Procedure: PECS II block

Interventions

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.

SPSIP Group
PECS II blockPROCEDURE

. 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.

PECS II group

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Select, 1234, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded study
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at Anesthesia & Surgical ICU and Pain Medicine

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 20, 2025

Study Start

February 27, 2025

Primary Completion

September 27, 2025

Study Completion

March 27, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations