- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362472
Comparison of Efficacy of Regional Blocks in Breast Surgeries.
January 15, 2026 updated by: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Comparison of Efficacy of Erector Spinae Plane Block Vs Combined Serratus Anterior Plane Block and Pecto-intercostal Fascial Plane Block in Patients Undergoing Breast Cancer Surgery
After Standardized anesthetic induction patients were randomly given regional blocks.
Group A recieved erecter spinae plane block & group B recieved combined serratous anterior and pecto-intercoatal facial plane block.
Their mean morphine consumption were followed for the next 24 hours.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects who are fulfilling the inclusion criteria will be included in the study after taking informed consent once approved by scientific review committee and Institutional review board.Subjects will be randomly divided into two groups by using a computer generated table using website Research Randomizer which will allocate the subjects randomly in two groups.Non probability consecutive sampling technique will used.Day cases are not included and major breast surgeries with post operative admission are included in study.Procedure will be done by the consultant having privilege to perform the block.Group A will be receiving ultrasound guided Erector spinae plane block before surgical incision with bupivacaine (maximum dose 2mg/kg) having total volume of 30ml.
Group B will receive ultrasound guided combined serratus anterior plane block( in which local anesthetic is injected between the serratus anterior and latissimus dorsi muscles at level of 5th rib in mid to posterior axillary line)and pecto-intercostal plane block(in which local anesthetic is injected between the pectoral and intercostal muscle layer in 4th rib pecto-sternal region)before surgical procedure with same dose of bupivacaine (maximum dose 2mg/kg) with total volume of 30ml.Induction of anesthesia will be done before block using 2-3mg/kg Propofol, 0.5mg/kg Atracurium and placement of supraglottic airway device will be done in each group as part of standardization(5).
Maintenance of anesthesia will be done with inhalational Sevoflurane, oxygen and air mixture.
Every patient will be given Paracetamol 1g and Diclofenac 75mg for analgesia and dexamethasone 8mg if not contraindicated intraoperatively.
Rescue analgesia with 0.05-0.1mg/kg
Morphine will be administered intraoperatively in a titrated fashion to all those patients for pain with 20% increase in Heart rate and blood pressure from base line.Ondansetron(0.1mg/kg)
IV as antiemetic and neostigmine/glycopyrrolate as a reversal agent will be used.Pain score will be assessed by RN registered nurse during first hour post operatively, at discharge from PACU using Numeric Rating Scale(NRS)and at 24 hours postoperatively on IPD using NRS and will be recorded in electronic record system of hospital.
Any patient with a score of more than 3 will be administered IV morphine (0.1mg/kg).
Post operative analgesic plan is multimodal with Paracetamol (1gm IV TID) and IV diclofenac 50mg BID (if no contraindication) along with opioid on PRN basis.
All data will be recorded on a Performa from electronic record system (attached at the end).
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female patients undergoing major breast cancer surgeries (modified radical mastectomy, breast reconstruction with implants).
- American society of anesthesiologist Grade 1 & 2
- Age between 18 to 45 years
Exclusion Criteria:
- Patient's refusal
- Emergency cases
- Patients having uncontrolled diseases like asthma, COPD or other lung diseases
- History of allergy from the drugs being used during the study
- Pregnant patients
- Patients with coagulopathies/bleeding disorders
- Patients undergoing bilateral major breast cancer surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erecter spinae plane block
Ultrasound guided 30ml erecter spinae plane block was provided with standard bupivacaine (2mg/kg)
|
In these interventions we compared two regional blocks (serratous anterior & pecto intercoastal facial plane block) techniques vs one regional block (erecter spinae plane block)
|
|
Active Comparator: serratous anterior plane block and pecto-intercoastal facial plane block
Ultrasound guided 30ml serratous anterior plane block and pecto-intercoastal facial plane block was provided with standard bupivacaine (2mg/kg)
|
In these interventions we compared two regional blocks (serratous anterior & pecto intercoastal facial plane block) techniques vs one regional block (erecter spinae plane block)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mean morphine consumption
Time Frame: 24 hours
|
We calculated and compared mean morphine consumption in first 24 hours post operatively among the 2 groups.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: 24 hours
|
We accessed pain scores post operatively in PACU at regular intervals and later on in inpatient for first 24 hours.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr. Hamood Ur Rehman, MBBS, Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2024
Primary Completion (Actual)
August 11, 2025
Study Completion (Actual)
August 27, 2025
Study Registration Dates
First Submitted
January 15, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 23, 2026
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- IRB-23-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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