Breast SurgeryNCT03344679
Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.
A study testing Bupivacaine 0.25%, Adenosine 12mg and Magnesium Sulphate 500 mg in people with Breast Surgery, run by Menoufia University.
Trial summary
Pectoral nerve block (PECS) has been used for post-operative pain relief in patients undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation. Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block techniques. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Breast Surgery
- What is being tested?
- Bupivacaine 0.25%, Adenosine 12mg and Magnesium Sulphate 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 22 Jul 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for modified radical mastectomy with axillary clearance surgery ASA classes I, II, and III patients were included in the study
Who cannot join
- 1) contraindications for regional anesthesia such as coagulopathy, local infection and fungating breast cancer, 2) history of allergy to the medications used in the study, 3) patient with history of drug abuse, 4) previous breast surgery except for diagnostic biopsies, 5) history of treatment for a chronic pain condition, 6) psychiatric disorder.
About this study
Official title: A Comparative Study of Ultrasound Guided PECS Block Using Bupivacaine Adenosine Versus Bupivacaine Magnesium Sulphate: A Randomised Controlled Trial.
Pectoral nerve block (PECS) has been used for post-operative pain relief in patients undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation. Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block techniques. We hypothesised that adenosine may affect the PECS block quality. We aimed to compare the effect of adding adenosine to the local anaesthetic and compare its effect to magnesium sulphate when used for PECS block.
Read the detailed description
The present study was conducted on 90 adult patients aged between 20 and 65 years old. Patients scheduled for modified radical mastectomy with axillary clearance surgery American Society of Anaesthetist (ASA) classes I, II, and III patients were included in the study.
Patients were randomly allocated into on of three groups according to the adjuvant used with the local anaesthetic, 30 patients in each group using a computerised program. All patients received PECS block. Group (C) received PECS block with 0.25% bupivacaine (control group), group (A) bupivacaine with added adenosine, and group (M) bupivacaine with added magnesium sulphate.
The local anaesthetic syringes were prepared by an independent anaesthetist. The researchers and the patients were blinded to the local anaesthetic adjuvant in the syringes. All patients received 30 ml local anaesthetic for PECS. The 30 ml local anaesthetic used for each patient contained bupivacaine hydrochloride 0.25%, bupivacaine hydrochloride 0.25% and 12 mg adenosine, and bupivacaine hydrochloride 0.25% and 500 mg magnesium sulphate for groups C, A, and M respectively.
Patients' demographic data were collected including age, BMI, ASA, and duration of surgery. In the post- anesthetic care unit (PACU) the visual analogue score (VAS) was assessed on arrival and then every 15 minutes. The duration and the quality of the block was recorded.
- Conditions
- Breast Surgery
- Being tested
- Bupivacaine 0.25%, Adenosine 12mg, Magnesium Sulphate 500 mg
- Keywords
- Pectoral nerve block, Adenosine, Magnesium sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25%Drug
Also called Control group
Bupivacaine 0.25% for PECS block
Adenosine 12mgDrug
Also called Adenosine
Adenosine 12 mg for PECS block
Magnesium Sulphate 500 mgDrug
Also called Magnesium sulphate
Magnesium sulphate 500 mg for PECS block
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Bupivacaine 0.25% for pectoral nerve block. Receives: Drug: Bupivacaine 0.25% |
| Adenosine | Other | Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block. Receives: Drug: Bupivacaine 0.25%; Drug: Adenosine 12mg |
| Magnesium sulphate | Other | Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block. Receives: Drug: Bupivacaine 0.25%; Drug: Magnesium Sulphate 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Visual analogue scale is a scale from 1 to 10 where 1 is no pain and 10 is the worst pain the patient experienced.
Measured: First 24 hours after surgery
Secondary outcomes (4)
Analgesic requirement
The total amount of morphine (mg) consumed by patients.
Measured: First 24 hours after surgery
PECS block duration.
The time from performing the block until the patient started to feel pain and the effect of the block faded.
Measured: First 24 hours after surgery
Mean arterial blood pressure (mmHg)
Mean arterial blood pressure reading.
Measured: Intra-operative (from induction of anaesthesia until the patient is awake)
Heart rate (beat/minute)
The number of hear beats per minute
Measured: Intra-operative(from induction of anaesthesia until the patient is awake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2015
- Primary completion15 Jun 2017
- Study completion22 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344679
- Sponsor's protocol ID
- MenoufiaU2015
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Ultrasound Guided PECS Block Using Bupivacaine Adenosine Versus Bupivacaine Magnesium Sulphate: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03344679
- Acronym / sponsor ID
- MenoufiaU2015
- Conditions
- Breast Surgery
- Keywords
- Pectoral nerve block, Adenosine, Magnesium sulphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 22 Jul 2017 (actual)
- First posted
- 17 Nov 2017 (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.
Pectoral nerve block (PECS) has been used for post-operative pain relief in patients undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation. Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block techniques. We hypothesised that adenosine may affect the PECS block quality. We aimed to compare the effect of adding adenosine to the local anaesthetic and compare its effect to magnesium sulphate when used for PECS block.
Detailed description
The present study was conducted on 90 adult patients aged between 20 and 65 years old. Patients scheduled for modified radical mastectomy with axillary clearance surgery American Society of Anaesthetist (ASA) classes I, II, and III patients were included in the study.
Patients were randomly allocated into on of three groups according to the adjuvant used with the local anaesthetic, 30 patients in each group using a computerised program. All patients received PECS block. Group (C) received PECS block with 0.25% bupivacaine (control group), group (A) bupivacaine with added adenosine, and group (M) bupivacaine with added magnesium sulphate.
The local anaesthetic syringes were prepared by an independent anaesthetist. The researchers and the patients were blinded to the local anaesthetic adjuvant in the syringes. All patients received 30 ml local anaesthetic for PECS. The 30 ml local anaesthetic used for each patient contained bupivacaine hydrochloride 0.25%, bupivacaine hydrochloride 0.25% and 12 mg adenosine, and bupivacaine hydrochloride 0.25% and 500 mg magnesium sulphate for groups C, A, and M respectively.
Patients' demographic data were collected including age, BMI, ASA, and duration of surgery. In the post- anesthetic care unit (PACU) the visual analogue score (VAS) was assessed on arrival and then every 15 minutes. The duration and the quality of the block was recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Bupivacaine 0.25%Bupivacaine 0.25% for pectoral nerve block. |
| Adenosine | Other | Drug: Bupivacaine 0.25%, Drug: Adenosine 12mgBupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block. |
| Magnesium sulphate | Other | Drug: Bupivacaine 0.25%, Drug: Magnesium Sulphate 500 mgBupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for modified radical mastectomy with axillary clearance surgery ASA classes I, II, and III patients were included in the study
Key exclusion criteria (1 listed)
- 1) contraindications for regional anesthesia such as coagulopathy, local infection and fungating breast cancer, 2) history of allergy to the medications used in the study, 3) patient with history of drug abuse, 4) previous breast surgery except for diagnostic biopsies, 5) history of treatment for a chronic pain condition, 6) psychiatric disorder.
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 |
|---|---|---|
| Bupivacaine 0.25%Also: Control groupBupivacaine 0.25% for PECS block | Drug | Adenosine, Control group, Magnesium sulphate |
| Adenosine 12mgAlso: AdenosineAdenosine 12 mg for PECS block | Drug | Adenosine |
| Magnesium Sulphate 500 mgAlso: Magnesium sulphateMagnesium sulphate 500 mg for PECS block | Drug | Magnesium sulphate |
Primary outcome
Visual analogue scale (VAS)
Time frame: First 24 hours after surgery
Visual analogue scale is a scale from 1 to 10 where 1 is no pain and 10 is the worst pain the patient experienced.
4 secondary outcomes
Analgesic requirement
Time frame: First 24 hours after surgery
PECS block duration.
Time frame: First 24 hours after surgery
Mean arterial blood pressure (mmHg)
Time frame: Intra-operative (from induction of anaesthesia until the patient is awake)
Heart rate (beat/minute)
Time frame: Intra-operative(from induction of anaesthesia until the patient is awake)
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 17 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Breast Surgery
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25%, Adenosine 12mg and Magnesium Sulphate 500 mg in people with Breast Surgery, run by Menoufia University.
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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual analogue scale (VAS) (time frame: First 24 hours after surgery). 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 17 Nov 2017.