Pain, PostoperativeRCTNCT05076773
TPVB, PECSB, ESPB for Postmastectmy Pain
A study testing Ultrasound guided block and IV morphine in people with Pain, Postoperative, run by Menoufia University at 1 site in Egypt.
Trial summary
Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ultrasound guided block and IV morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2019to 10 Aug 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status classification class I or II
- Age group 18 - 60 years of the female gender
- Patients undergoing breast cancer surgeries
Who cannot join
- Patient refusal
- History of hypersensitivity to local anesthetics
- Bleeding disorders or patients receiving anticoagulants
- Spine or chest wall deformities
- Pregnancy
- Local infection at the site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Menofia University
Shibīn al Kawm, Menofia, 32511
About this study
Official title: A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study
Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.
- Conditions
- Pain, Postoperative
- Being tested
- Ultrasound guided block, IV morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided blockProcedure or surgery
Also called Us guided paravertebral block, Us guided erector spinae block, Us guided PECs 1 and 2
Giving one regional block
IV morphineDrug
given when VAS>3
| Study group | Role | What they receive |
|---|---|---|
| Control Group (D) | Placebo comparator | Patient will receive opioid only for management of their perioperative pain Receives: Drug: IV morphine |
| Paravertebral block Group (A) | Active comparator | Will receive thoracic paravertebral block Receives: Procedure: Ultrasound guided block; Drug: IV morphine |
| Pectoral block Group (B) | Active comparator | Will receive pectoral 1 and 2 block Receives: Procedure: Ultrasound guided block; Drug: IV morphine |
| Erector spinae block Group (C) | Active comparator | Will receive erector spinae block Receives: Procedure: Ultrasound guided block; Drug: IV morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
minutes
Measured: 0-24o minutess
Secondary outcomes (3)
Postoperative pain
assessed by VAS score (0-10) where 0=no pain and 10=worst pain
Measured: 48 hours
Total morphine consumption
recorded postoperatively in mg
Measured: 48 hours
Postoperative nausea and vomiting (PONV)
4 points score of PONV (0-3) where 0=no PONV and 3=vomiting more than once
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start10 Apr 2019
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kareem Mikhamer, Menoufia University
- Investigators
- kareem M mikhimer, m.sc, Principal investigator, assistant fellow, Ahmed Maher Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076773
- Sponsor's protocol ID
- 32900654326
- Acronym
- RCT
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Title only
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05076773
- Acronym / sponsor ID
- RCT / 32900654326
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 13 Oct 2021 (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.
Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group (D) | Placebo comparator | Drug: IV morphinePatient will receive opioid only for management of their perioperative pain |
| Paravertebral block Group (A) | Active comparator | Procedure: Ultrasound guided block, Drug: IV morphineWill receive thoracic paravertebral block |
| Pectoral block Group (B) | Active comparator | Procedure: Ultrasound guided block, Drug: IV morphineWill receive pectoral 1 and 2 block |
| Erector spinae block Group (C) | Active comparator | Procedure: Ultrasound guided block, Drug: IV morphineWill receive erector spinae block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status classification class I or II
- Age group 18 - 60 years of the female gender
- Patients undergoing breast cancer surgeries
Key exclusion criteria (6 listed)
- Patient refusal
- History of hypersensitivity to local anesthetics
- Bleeding disorders or patients receiving anticoagulants
- Spine or chest wall deformities
- Pregnancy
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 |
|---|---|---|
| Ultrasound guided blockAlso: Us guided paravertebral block, Us guided erector spinae block, Us guided PECs 1 and 2Giving one regional block | Procedure or surgery | Erector spinae block Group (C), Paravertebral block Group (A), Pectoral block Group (B) |
| IV morphinegiven when VAS>3 | Drug | Control Group (D), Erector spinae block Group (C), Paravertebral block Group (A), Pectoral block Group (B) |
Primary outcome
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
Time frame: 0-24o minutess
minutes
3 secondary outcomes
Postoperative pain
Time frame: 48 hours
Total morphine consumption
Time frame: 48 hours
Postoperative nausea and vomiting (PONV)
Time frame: 48 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 13 Oct 2021.
- Individual participant dataSharing planned: No. Title only
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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.
kareem M mikhimer, m.sc principal investigator
assistant fellow, Ahmed Maher Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided block and IV morphine in people with Pain, Postoperative, run by Menoufia University at 1 site in Egypt.
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 6 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 13 Oct 2021. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block). (time frame: 0-24o minutess). 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 13 Oct 2021.