Pain ScoreNCT07362472
Comparison of Efficacy of Regional Blocks in Breast Surgeries.
A study testing Regional nerve blocks in people with Pain Score and Morphine Consumption, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Score, Morphine Consumption
- What is being tested?
- Regional nerve blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Nov 2024to 27 Aug 2025
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore
Lahore, Punjab Province
About this study
Official title: 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.
Read the 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).
- Conditions
- Pain Score, Morphine Consumption
- Being tested
- Regional nerve blocks
- Keywords
- Breast surgeries, Erecter spinae plane, serratous anterior plane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional nerve blocksProcedure or surgery
In these interventions we compared two regional blocks (serratous anterior \& pecto intercoastal facial plane block) techniques vs one regional block (erecter spinae plane block)
| Study group | Role | What they receive |
|---|---|---|
| Erecter spinae plane block | Active comparator | Ultrasound guided 30ml erecter spinae plane block was provided with standard bupivacaine (2mg/kg) Receives: Procedure: Regional nerve blocks |
| serratous anterior plane block and pecto-intercoastal facial plane block | Active comparator | Ultrasound guided 30ml serratous anterior plane block and pecto-intercoastal facial plane block was provided with standard bupivacaine (2mg/kg) Receives: Procedure: Regional nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean morphine consumption
We calculated and compared mean morphine consumption in first 24 hours post operatively among the 2 groups.
Measured: 24 hours
Secondary outcomes (1)
Pain score
We accessed pain scores post operatively in PACU at regular intervals and later on in inpatient for first 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start7 Nov 2024
- Primary completion11 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ScoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Hamood Ur Rehman, MBBS, Principal investigator, Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362472
- Sponsor's protocol ID
- IRB-23-11
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
PubMed 32660716
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07362472
- Acronym / sponsor ID
- IRB-23-11
- Conditions
- Pain Score, Morphine Consumption
- Keywords
- Breast surgeries, Erecter spinae plane, serratous anterior plane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Erecter spinae plane block | Active comparator | Procedure: Regional nerve blocksUltrasound guided 30ml erecter spinae plane block was provided with standard bupivacaine (2mg/kg) |
| serratous anterior plane block and pecto-intercoastal facial plane block | Active comparator | Procedure: Regional nerve blocksUltrasound guided 30ml serratous anterior plane block and pecto-intercoastal facial plane block was provided with standard bupivacaine (2mg/kg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional nerve blocksIn these interventions we compared two regional blocks (serratous anterior \& pecto intercoastal facial plane block) techniques vs one regional block (erecter spinae plane block) | Procedure or surgery | Erecter spinae plane block, serratous anterior plane block and pecto-intercoastal facial plane block |
Primary outcome
mean morphine consumption
Time frame: 24 hours
We calculated and compared mean morphine consumption in first 24 hours post operatively among the 2 groups.
1 secondary outcome
Pain score
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 32660716Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Hamood Ur Rehman, MBBS principal investigator
Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional nerve blocks in people with Pain Score and Morphine Consumption, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 3 inclusion and 7 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 23 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 Pakistan. 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?
mean morphine consumption (time frame: 24 hours). 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 NCT07362472, 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 23 Jan 2026.