CTRI

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CTRI Number

CTRI/2025/09/093987 [Registered on: 01/09/2025] Trial Registered Prospectively

Last Modified On:

31/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Ultrasound guided nerve blocks for pain relief in females undergoing breast cancer surgery: What works best?

Scientific Title of Study

Comparing the quality of post operative analgesia between ultrasound guided serratus anterior plane block and pectoral nerve block in female patients undergoing breast cancer surgery - a prospective randomised single blinded study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Darshini Gowramma A G
Designation	Postgraduate resident
Affiliation	Karnataka Medical College and Research Institute Hubballi
Address	Department of anaesthesiology Room number 206 Second floor IP building Karnataka Medical College and Research Institute Vidyanagar Hubballi Dharwad KARNATAKA 580021 India
Phone	8296640573
Fax
Email	darshinigowramma@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Veena K
Designation	Associate Professor
Affiliation	Karnataka Medical College and Research Institute Hubballi
Address	Department of anaesthesiology Room number 206 Second floor IP building Karnataka Medical College and Research Institute Vidyanagar Hubballi Dharwad KARNATAKA 580021 India
Phone	9482066502
Fax
Email	veenakaggalagoudar3149@gmail.com

Details of Contact Person
Public Query

Name	Dr Veena K
Designation	Associate Professor
Affiliation	Karnataka Medical College and Research Institute Hubballi
Address	Department of anaesthesiology Room number 206 Second floor IP building Karnataka Medical College and Research Institute Hubballi Vidyanagar Hubballi Dharwad KARNATAKA 580021 India
Phone	9482066502
Fax
Email	veenakaggalagoudar3149@gmail.com

Source of Monetary or Material Support

Department of anaesthesiology Room number 206 Second floor IP building Karnataka Medical College and Research Institute Vidyanagar Hubballi Pincode 580021 Karnataka India

Primary Sponsor

Name	Dr Darshini Gowramma A G
Address	Department of anaesthesiology Room number 206 Second floor IP building Karnataka Medical College and Research Institute Vidyanagar Hubballi Pincode 580021 Karnataka India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Darshini Gowramma A G	Karnataka Medical College and Research Institute Hubballi 580021 Karnataka India	Surgical Major OT Room number 205 Second floor IP building Surgical oncology OT Fifth floor PMSSY superspeciality hospital Dharwad KARNATAKA	8296640573 darshinigowramma@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Karnataka Medical College and Research Institute, Hubballi Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C508\|\|Malignant neoplasm of overlappingsites of breast,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Ultrasound guided pectoral nerve block	In PECS block, the patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The high frequency probe, 13–6 MHz transducer will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be angled caudally to look for the pulsating pectoral branch of the thoracoacromial artery; if not found, the probe to be pushed 1–2 cm caudally and medially. In a caudal tilt, within a bi convex space, the artery will be recognised. After that, 10 mL of 0.25% bupivacaine will be administered. The probe will then be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attached to the underlying ribs. The third and fourth ribs will be seen. The needle will target the plane between the serratus and the third rib, followed by negative aspiration and injection of 20 mL of 0.25% bupivacaine into the fascial plane.
Intervention	Ultrasound guided serratus anterior plane block	In the serratus plane block group, the patient will lay in supine position and US-guided serratus block will be performed. The ribs will be counted, and the high-frequency probe will be placed over the fourth rib in the mid-axillary line in a sagittal plane. When the ribs, pleura, latissimus dorsi muscle, teres major muscle, and overlaying serratus muscle will be detected, needle will be pushed cephalad until the needle tip reaches the fourth rib. After that, 30 mL of 0.25% bupivacaine will be injected deep to the serratus muscle.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	1 American Society of Anesthesiologists physical status I to III 2 Patients undergoing elective breast cancer surgery

ExclusionCriteria

Details

1 Allergic history to local anesthetics use
2 Psychiatric disease
3 Chronic opioid usage defined as more than 3 months preoperatively
4 Chronic pain diagnosis
5 Prolonged postoperative intubation
6 Pregnancy
7 BMI of less than 18.5 kg per meter square or more than 24.9 kg per meter square

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
While both SAP and PECS blocks are expected to potentially reduce pain in patients undergoing breast cancer surgery by providing analgesia to the lateral and anterior chest wall, we are curious to know about the time to first analgesic request, postoperative analgesia, perioperative opioid consumption and patient satisfaction	Right after extubation At 2 hours post operatively At 6 hours post operatively At 12 hours post operatively At 24 hours post operatively

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

15/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Breast cancer ranks first among the most common malignant neoplasms in

women. Breast cancer surgery procedures are characterized by moderate and

severe pain. Acute postoperative pain is reported in around 40% of breast cancer

patients, indicating that post operative pain treatment is insufficient. In addition,

acute postoperative pain could reduce the quality of life by increasing

the probability of post mastectomy pain syndrome. Insufficient postoperative

acute pain control is associated with increased morbidity, delayed wound healing,

lengthened hospital stay, increased side effects secondary to opioid use, chronic

pain, and high care costs. Postoperative chronic pain and long-term opioid

addiction risks after breast cancer surgery are reported to be 29 % and 11 %,

respectively.

Regional anaesthesia has an important role in the multimodal analgesia regimen

following breast surgery. The paravertebral block is considered the traditional

regional anaesthetic procedure of choice for postmastectomy pain and has shown

its ability to reduce postoperative pain scores, opioid consumption, and the

severity of chronic pain compared to general anaesthesia alone. However, this

block is also associated with negative effects and complications such as

hypotension, unintentional epidural injection, and difficulties with optimal

placement of block. In the last decade, various ultrasound (US) guided thoracic

wall blocks [pectoralis (PECS I, PECS II) nerve block, modified PECS II block,

serratus anterior plane (SAP) block] have been developed to provide reliable

analgesia in patients undergoing breast cancer surgery. The emergence of

fascial plane blocks has provided a simple, easy-to-learn alternative that lacks

many of the side effects seen with previous regional techniques used for

oncological breast procedures. In particular, the SAP and PECS blocks are

effective in breast surgery by providing analgesia to the anterior and lateral chest

walls.

In studies comparing post-mastectomy acute pain control, the thoracic

paravertebral block was outperformed by the PECS block, and the serratus anterior

plane block was reported to be less effective than the thoracic paravertebral block.

Various studies comparing PECS and SAP blocks have shown conflicting results

regarding superiority of one block over the other. Hence, this study aims to

compare the quality of post operative analgesia produced with ultrasound guided

PECS block versus the SAP block in female patients undergoing breast cancer

surgeries.