Postoperative PainNCT03944759
Efficacy of Serratus Anterior Plane Block Mastectomy
A study testing serratus anterior plan block in people with Postoperative Pain and Postoperative Complications, run by doaa rashwan at 1 site in Egypt.
Trial summary
Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients . Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Complications
- What is being tested?
- serratus anterior plan block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2019to 1 Dec 2019
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II female patients, age 25-60 undergoing breast cancer surgery
Who cannot join
- -Patient refusal
- Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
- Allergy to the drugs used in the study
- Chronic pain therapy,
- BMI more than 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Serratus Anterior Plane Block Using Bupivacaine/Magnesium Sulphate Versus Bupivacaine/Nalbuphine for Mastectomy: a Randomized Double Blinded Comparative Study
Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .
Read the detailed description
The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.
Patients and methods nclusion criteria:
-ASA I and II female patients, age 25-60 undergoing breast cancer surgery
Exclusion criteria:
- Patient refusal
- Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
- Allergy to the drugs used in the study
- Chronic pain therapy,
- BMI more than 30 kg/m2
- Conditions
- Postoperative Pain, Postoperative Complications
- Being tested
- serratus anterior plan block
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior plan blockProcedure or surgery
serratus anterior plan block
| Study group | Role | What they receive |
|---|---|---|
| GBM:( bupivacaine/magnesium sulphate) | Active comparator | serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.
GBM:( bupivacaine/magnesium sulphate): will receive bupivacaine 30 ml 0.25 and 500 mg magnesium sulphate Receives: Procedure: serratus anterior plan block |
| GBN: ( bupivacaine/nalpuphin) | Active comparator | serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.. ( bupivacaine/nalpuphin):received bupivacaine 30 ml 0.25 % and nalpuphine 0.2mg/kg. Receives: Procedure: serratus anterior plan block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesic requirements in minutes
time to first analgesic requirements in minutes by the patient
Measured: change from base line for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start7 May 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- doaa rashwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, doaa rashwan, Beni-Suef University
- Investigators
- Doaa Rashwan, MD, Study director, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944759
- Sponsor's protocol ID
- FMBSURECS/30042019/Ali
- Status last verified
- Feb 2020
- First submitted
- 6 May 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the protocol
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serratus Anterior Plane Block Using Bupivacaine/Magnesium Sulphate Versus Bupivacaine/Nalbuphine for Mastectomy: a Randomized Double Blinded Comparative Study
- ClinicalTrials.gov ID
- NCT03944759
- Acronym / sponsor ID
- FMBSURECS/30042019/Ali
- Conditions
- Postoperative Pain, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- doaa rashwanUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 May 2019 (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.
Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .
Detailed description
The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.
Patients and methods nclusion criteria:
-ASA I and II female patients, age 25-60 undergoing breast cancer surgery
Exclusion criteria:
- Patient refusal
- Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
- Allergy to the drugs used in the study
- Chronic pain therapy,
- BMI more than 30 kg/m2
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBM:( bupivacaine/magnesium sulphate) | Active comparator | Procedure: serratus anterior plan blockserratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia. GBM:( bupivacaine/magnesium sulphate): will receive bupivacaine 30 ml 0.25 and 500 mg magnesium sulphate |
| GBN: ( bupivacaine/nalpuphin) | Active comparator | Procedure: serratus anterior plan blockserratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.. ( bupivacaine/nalpuphin):received bupivacaine 30 ml 0.25 % and nalpuphine 0.2mg/kg. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I and II female patients, age 25-60 undergoing breast cancer surgery
Key exclusion criteria (5 listed)
- -Patient refusal
- Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
- Allergy to the drugs used in the study
- Chronic pain therapy,
- BMI more than 30 kg/m2
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 |
|---|---|---|
| serratus anterior plan blockserratus anterior plan block | Procedure or surgery | GBM:( bupivacaine/magnesium sulphate), GBN: ( bupivacaine/nalpuphin) |
Primary outcome
time to first analgesic requirements in minutes
Time frame: change from base line for 24 hours
time to first analgesic requirements in minutes by the patient
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 12 Feb 2020.
- Individual participant dataSharing planned: Yes. the protocol
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Doaa Rashwan, MD study director
Faculty of Medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus anterior plan block in people with Postoperative Pain and Postoperative Complications, run by doaa rashwan 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 1 inclusion and 5 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 12 Feb 2020. 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?
time to first analgesic requirements in minutes (time frame: change from base line for 24 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 12 Feb 2020.