Injection Site HaematomaSAPBNCT05126394
U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM
A study testing ultrasound guided serratus anterior plane block in people with Injection Site Haematoma and Local Anesthetic Toxicity, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM) Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injection Site Haematoma, Local Anesthetic Toxicity
- What is being tested?
- ultrasound guided serratus anterior plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2020to 10 Oct 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged between 20-60 years old.
- Preoperative physical status: ASA (American Society of Anesthesiology) I \& II.
- Body mass index (BMI) < 35 Kg/ m2.
- Candidate for unilateral modified radical mastectomy.
- Informed consent to participate in the study.
Who cannot join
- - Females aged < 20 years old or > 60 years old.
- Preoperative physical status: ASA III \& IV.
- Morbid obese patients with BMI > 35 Kg/ m2.
- Refusal to participate in the study.
- Addiction to narcotics or psycho-active drugs.
- Psychological disorders.
- Contra-indications to regional anesthesia (coagulopathy, injection site infection or allergy to any of the study drugs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM)
Read the detailed description
All patients undergoing modified radical mastectomy were assigned to one of the following two groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and Group B: IV analgesics group (control group): this group consists of 20 patients who did not receive any type of block.Further evaluations were carried out by a different investigator who was unaware of the patients' grouping. The degree of post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours using the VAS score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours.
Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline, were given Pethidine (50 mg IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline but still complaining; Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.
- Being tested
- ultrasound guided serratus anterior plane block
- Keywords
- "SAPB", "MRM", "pain management"
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided serratus anterior plane blockProcedure or surgery
the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( SAPB) group | Experimental | this group of patients receives serratus anterior plane block, just after induction of anesthesia. Receives: Procedure: ultrasound guided serratus anterior plane block |
| Group B: control group | No intervention | this group of patients does not receive any blockade, they receive conventional IV analgesics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of first rescue analgesic
the time taken by the patient to receive first dose of rescue analgesia, guided by the patients VAS score ( if the patients VAS score is 4 or more, the patient receives 50 mg of Pethidine).
Measured: it is measured for 24 hours after the end of surgery.
total dose of rescue analgesics
the total dose of Pethidine needed by each patient measured in mg.
Measured: it is measured for 24 hours after the end of surgery.
Secondary outcomes (3)
patients satisfaction
patients satisfaction is measured on a scale from 0 to 10, where 0 means not satisfied at all and 10 means the ultimate satisfaction.
Measured: 24 hours after the end of surgery.
incidence of nausea and vomiting
patients are assessed for incidence of postoperative nausea and vomiting.
Measured: 24 hours after the end of surgery.
incidence of any block related complications.
incidence of any serratus anterior plane block complications (e.g. injection site hematoma, signs and/or symptoms of local anesthetic toxicity ) is detected.
Measured: 24 hours after the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Mar 2020
- Primary completion10 Oct 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site HaematomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hala Gomaa Salama, Medical Doctorate, Study director, Anesthesia department, Ain Shams University, Cairo, Egypt.Hanan Mahmoud Farag, Medical Doctorate, Study director, Anesthesia department, Ain Shams University, Cairo, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126394
- Sponsor's protocol ID
- FMASU MD 209a / 2021
- Acronym
- SAPB
- Status last verified
- Mar 2020
- First submitted
- 26 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05126394
- Acronym / sponsor ID
- SAPB / FMASU MD 209a / 2021
- Keywords
- "SAPB", "MRM", "pain management"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 19 Nov 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.
The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM)
Detailed description
All patients undergoing modified radical mastectomy were assigned to one of the following two groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and Group B: IV analgesics group (control group): this group consists of 20 patients who did not receive any type of block.Further evaluations were carried out by a different investigator who was unaware of the patients' grouping. The degree of post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours using the VAS score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours.
Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline, were given Pethidine (50 mg IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline but still complaining; Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group A ( SAPB) group | Experimental | Procedure: ultrasound guided serratus anterior plane blockthis group of patients receives serratus anterior plane block, just after induction of anesthesia. |
| Group B: control group | No intervention | –this group of patients does not receive any blockade, they receive conventional IV analgesics. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females aged between 20-60 years old.
- Preoperative physical status: ASA (American Society of Anesthesiology) I \& II.
- Body mass index (BMI) < 35 Kg/ m2.
- Candidate for unilateral modified radical mastectomy.
- Informed consent to participate in the study.
Key exclusion criteria (7 listed)
- - Females aged < 20 years old or > 60 years old.
- Preoperative physical status: ASA III \& IV.
- Morbid obese patients with BMI > 35 Kg/ m2.
- Refusal to participate in the study.
- Addiction to narcotics or psycho-active drugs.
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 serratus anterior plane blockthe patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance. | Procedure or surgery | Group A ( SAPB) group |
Primary outcome
the time of first rescue analgesic
Time frame: it is measured for 24 hours after the end of surgery.
the time taken by the patient to receive first dose of rescue analgesia, guided by the patients VAS score ( if the patients VAS score is 4 or more, the patient receives 50 mg of Pethidine).
total dose of rescue analgesics
Time frame: it is measured for 24 hours after the end of surgery.
the total dose of Pethidine needed by each patient measured in mg.
3 secondary outcomes
patients satisfaction
Time frame: 24 hours after the end of surgery.
incidence of nausea and vomiting
Time frame: 24 hours after the end of surgery.
incidence of any block related complications.
Time frame: 24 hours after the end of surgery.
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 19 Nov 2021.
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.
Hala Gomaa Salama, Medical Doctorate study director
Anesthesia department, Ain Shams University, Cairo, Egypt.
Hanan Mahmoud Farag, Medical Doctorate study director
Anesthesia department, Ain Shams University, Cairo, Egypt.
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 serratus anterior plane block in people with Injection Site Haematoma and Local Anesthetic Toxicity, run by Ain Shams 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 5 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 19 Nov 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. 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 time of first rescue analgesic (time frame: it is measured for 24 hours after the end of surgery.). The study lists 2 primary outcomes in all. 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 19 Nov 2021.