CancerNCT07197177
PECTORAL PLANE BLOCK COMPAIRED TO ERECTOR SPINAE PLANE BLOCK IN MULTIMODAL ANALGESIA FOR MASTECTOMY PATIENTS IN SOUTH ASIAN POPULATION -A PROSPECTIVE RANDOMISED CONTROL TRIAL
A study testing regional block in people with Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- regional block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 25 Dec 2021
- 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA physical status II or III, biopsy proven breast cancer, and were undergoing unilate l modified radical mastectomy
Who cannot join
- . Exclusion criteria included patient refusal to participate, age less than 18 years, diagnosed allergy or contraindication to local anesthetic, chronic pain, obesity (BMI >35), non-cancerous or undiagnosed breast lesions, ASA IV status, and emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group.
Read the detailed description
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group
- Conditions
- Cancer
- Being tested
- regional block
- Keywords
- Regional anesthesia
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional blockProcedure or surgery
We will infiltrate local anesthesia (Bupivicaine 0.25 %), in pectoral plane vs Erecter spine plane, will observe intraoperative morphine consumption, pain scores and Pacu stay.
| Study group | Role | What they receive |
|---|---|---|
| PECTORAL PLANE BLOCK | Experimental | We will infiltrate local anesthesia in Pectoral Plane under ultrasound guidance. Receives: Procedure: regional block |
| ERECTOR SPINAE PLANE BLOCK | Experimental | We will infiltrate local anesthesia in ERECTOR spine Plane under ultrasound guidance. Receives: Procedure: regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Morphine consumption
calculate morphine consumption intraoperatively and post operative at 12 hours
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Jan 2021
- Primary completion25 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197177
- Sponsor's protocol ID
- IRB-21-22
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PECTORAL PLANE BLOCK COMPAIRED TO ERECTOR SPINAE PLANE BLOCK IN MULTIMODAL ANALGESIA FOR MASTECTOMY PATIENTS IN SOUTH ASIAN POPULATION -A PROSPECTIVE RANDOMISED CONTROL TRIAL
- ClinicalTrials.gov ID
- NCT07197177
- Acronym / sponsor ID
- IRB-21-22
- Conditions
- Cancer
- Keywords
- Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 29 Sep 2025 (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.
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group.
Detailed description
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECTORAL PLANE BLOCK | Experimental | Procedure: regional blockWe will infiltrate local anesthesia in Pectoral Plane under ultrasound guidance. |
| ERECTOR SPINAE PLANE BLOCK | Experimental | Procedure: regional blockWe will infiltrate local anesthesia in ERECTOR spine Plane under ultrasound guidance. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status II or III, biopsy proven breast cancer, and were undergoing unilate l modified radical mastectomy
Key exclusion criteria (1 listed)
- . Exclusion criteria included patient refusal to participate, age less than 18 years, diagnosed allergy or contraindication to local anesthetic, chronic pain, obesity (BMI >35), non-cancerous or undiagnosed breast lesions, ASA IV status, and emergency surgery.
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 blockWe will infiltrate local anesthesia (Bupivicaine 0.25 %), in pectoral plane vs Erecter spine plane, will observe intraoperative morphine consumption, pain scores and Pacu stay. | Procedure or surgery | ERECTOR SPINAE PLANE BLOCK, PECTORAL PLANE BLOCK |
Primary outcome
Mean Morphine consumption
Time frame: 12 hours
calculate morphine consumption intraoperatively and post operative at 12 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 29 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 block in people with Cancer, 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 1 inclusion and 1 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 29 Sep 2025. 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: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.