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CancerPhase 2NCT05663801

Magnesium Sulphate Versus Ketamine as an Adjuvant to Bupivacaine in Pectoral Nerve Block During Mastectomy

A Phase 2 study testing Use of Bupivacaine in pectoral nerve block in mastectomy, use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy and Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy in people with Cancer and Breast, run by Beni-Suef University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are no published article that compare magnesium sulfate and ketamine as adjuvants to bupivacaine in PECS block , so the aim of this study is to evaluate the efficacy of Magnesium sulfate versus ketamine when added to local anesthetic ( Bupivacaine) in pectoral nerve block during mastectomy and detect which of… Read more about this study

Who is it for?
Ages 30 to 70 years, women only
Conditions the study is for
Cancer, Breast
What is being tested?
Use of Bupivacaine in pectoral nerve block in mastectomy, use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy and Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteEgypt
Study dates
1 Dec 2022to 1 May 2024
Phase
Phase 2
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 30 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patient
  • Age from 30 to 70 years old
  • American Society of Anesthesiologists (ASA) I-II

Who cannot join

  • Cognitive impairment
  • History of alcohol or drug abuse
  • Allergy to the studied drugs
  • Patients with coagulation disorders
  • Block site infection
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Body Mass Index( BMI) more than 30 kg/m2

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • faculty of medicine ,Beni-Suef university

    Banī Suwayf, Beni Suweif Governorate, 62511

Other trials in Egypt

About this study

Official title: Efficacy Of Magnesium Sulphate Versus Ketamine as an Adjuvant to Bupivacaine in Pectoral Nerve Block During Mastectomy : Comparative Controlled , Randomized Double-Blind Study

There are no published article that compare magnesium sulfate and ketamine as adjuvants to bupivacaine in PECS block , so the aim of this study is to evaluate the efficacy of Magnesium sulfate versus ketamine when added to local anesthetic ( Bupivacaine) in pectoral nerve block during mastectomy and detect which of these drugs has the more effective analgesic effect and decrease opioid consumption .

Read the detailed description

Breast cancer is the most common malignancy in females, and its incidence increases with increase the age of the patients and it is the most expected cause of death in the world .

Surgery is the main treatment of breast cancer and other treatments include chemotherapy, radiotherapy , hormonal therapy and biological therapy or combination treatment and this depends on the type of the cancer and its stage .

Breast surgery is usually associated with significant postoperative pain. Poorly controlled postoperative pain has a negative physiological and psychological impacts as it is associated with an increase in hospital stay , medical care cost, significant postoperative nausea and vomiting , development of chronic pain syndrome and impaired quality of life .

Several methods have been involved in postoperative pain control including multi modal analgesia using multiple medication with different mechanism of action as intravenous and oral opioids , non-steroidal anti-inflammatory drugs and local anesthetic infiltration also has an important role in pain control .

Regional anesthetic procedures have an effective role in acute pain control as thoracic epidural and thoracic paravertebral block are considered the gold standard procedures for postoperative pain management for breast cancer surgery, but not every anesthesiologist is comfortable making these invasive procedures .

Recently, the pectoral nerves blocks (PECS I and PECS II) are recommended for providing intraoperative and postoperative pain control during and after breast surgery. These blocks may be more effective when compared to other regional anesthetic procedures .

Pectoral nerves blocks includes 2 types (PECS I and PECS II). The PECS block type I is a easy and reliable performed by injection an interfacial plane between the pectoralis major and pectoralis minor muscles to block the lateral region of the breast to provide analgesia for breast surgery .

The PECS block type II "modified Pecs's block'' is performed by injection at the interfascial plane between the pectoralis minor muscle and serratus anterior muscle . It aims at blocking the pectoral nerves, the intercostobrachial , intercostals (III, IV, V, and VI), and the long thoracic nerve and these are required to block the axilla also provides analgesia to mammary glands and the skin from the T2-T6 dermatomes extending into the mid-axillary line providing complete analgesia during breast surgery and several types of mastectomies .

Pectoral nerve block is usually performed using an in-line needling technique by ultrasound guidance, which is essential to identify the plane between the pectoralis major, minor muscles, and serratus anterior as well as the anatomical landmarks associated with them .

Hematoma and local anesthetic toxicity and risk of pneumothorax are adverse effects in pectoral nerve block especially PECS II block which may be reduced by using ultrasound guidance and decreasing anesthetic drug concentrations .

Various adjuvants, as fentanyl, morphine, tramadol, epinephrine, α2 agonists, dexamethasone, midazolam, neostigmine and sodium bicarbonate have been added to local anesthetics agents to prolong the time and potency of postoperative analgesia and this is may be associated with adverse effects, and the outcomes have been inadequate.

An understanding of pain mechanisms points to the role of central sensitization and N-methyl-D-aspartate (NMDA) receptor activation by excitatory amino acid transmitters in postsurgical pain .

Magnesium sulfate (MgSO4) is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor in the central and peripheral nervous system, and is found to decrease the intraoperative and postoperative analgesic consumption and also it increases the duration and potency of analgesia when combined with different local anesthetics.

Magnesium augments local anesthetics (LA) action in the peripheral nerves by increasing the firing threshold in both myelinated and unmyelinated axons increasing the transmembrane potential causing hyperpolarization and adding of magnesium to bupivacaine produces an enhancement of nerve blocking .

Ketamine is also a non-competitive antagonist of the N-methyl-D-aspartate NMDA receptor antagonist commonly used for its analgesic and anesthetic effect .

Ketamine decreases the intensity of postoperative pain, reduces 24-hour opioid consumption, and delays the time to first request of analgesic therapy .

Bupivacaine is an amide local anesthetic with a slow onset, long duration of action and high potency. The maximum recommended single bolus dose of bupivacaine is 2.5 mg/Kg, bupivacaine exert its action through impairing sodium influx across the neuronal membrane by blocking the sodium channels .

Conditions
Cancer, Breast
Being tested
Use of Bupivacaine in pectoral nerve block in mastectomy, use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy, Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy
Keywords
Magnesium sulphate, ketamine, PECS block, Mastectomy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of Bupivacaine in pectoral nerve block in mastectomyDrug

    Also called marcain

    Pectoral nerve block will be performed and patients will be given 30 mL of 0.25% bupivacaine hydrochloride and It will be divided into 10 mL injected between the 2 pectoral muscles on the interfascial plane, and 20 mL will be injected between the pectoralis minor and the serratus anterior muscles

  • use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomyDrug

    Also called ketalar

    Pectoral nerve block will be performed and Patients will be given 30 mL of 0.25% bupivacaine hydrochloride plus ketamine hydrochloride (1 mg/kg) and It will be divided into 10 mL injected between the 2 pectoral muscles on the interfascial plane, and 20 mL will be injected between the pectoralis minor and the serratus anterior muscles

  • Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomyDrug

    Also called Mgso4

    Pectoral nerve block will be performed and Patients will be given 30 mL 0.25% Bupivacaine hydrochloride plus Magnesium Sulfate ( 28 ml Bupivacaine 0.25% plus 2ml magnesium sulfate 50%) and It will be divided into 10 mL injected between the 2 pectoral muscles on the interfascial plane, and 20 mL will be injected between the pectoralis minor and the serratus anterior muscles

Study groups in NCT05663801
Study groupRoleWhat they receive
Group A (control group )Active comparatorPatients will be given 30 mL of 0.25% bupivacaine hydrochloride in pectoral nerve block .
Receives: Drug: Use of Bupivacaine in pectoral nerve block in mastectomy
Group B ( Ketamine group)Active comparatorPatients will be given 30 mL of 0.25% bupivacaine hydrochloride plus ketamine hydrochloride (1 mg/kg) in pectoral nerve block .
Receives: Drug: use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy
Group C (Magnesium sulfate group)Active comparatorPatients will be given 30 mL 0.25% bupivacaine hydrochloride plus magnesium sulfate ( 28 ml bupivacaine 0.25% plus 2ml magnesium sulfate (50%) in pectoral nerve block
Receives: Drug: Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The postoperative time to first request of analgesia

    the aim of this study is to evaluate the efficacy of Magnesium sulfate versus ketamine when added to local anesthetic (Bupivacaine) in pectoral nerve block during mastectomy and the first time of request of analgesia postoperative in hours is the primary outcome

    Measured: up to 24 hours

Secondary outcomes (6)
  1. Visual Analogue Scale (VAS) , the scale is determined by measuring the distance in millimeter (mm) on the 10 centimeter (cm) line between the 0 (no pain ) and the mark of the patient .

    All patients will be followed up and assessed at baseline, one hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours, postoperative for Visual Analogue Scale (VAS) to assess the pain intensity ,The Visual Analogue Scale VAS consists of a 10 cm line with two end points representing 0(no pain ) and 10 (worst pain )

    Measured: up to 24 hours

  2. Postoperative analgesic requirements( (pethidine in milligram/ kilogram (mg/kg) )

    All patients will be followed up and assessed at baseline, one hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours, postoperative for visual analogue scale to assess pain intensity and pethidine will be given 0.2-0.5 mg/kg if visual analogue scale (VAS) scale ≥ 3)

    Measured: up to 24 hours

  3. Postoperative heart rate (Beat/minute)

    All patients will be followed up and assessed at baseline, one hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours, postoperative for heart rate measurement (Beat/minute)

    Measured: up to 24 hours

  4. Postoperative non invasive mean arterial blood pressure in millimeters of mercury (mmHg)

    All patients will be followed up and assessed at baseline, one hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours, postoperative for non invasive blood pressure measurement in millimeters of mercury (mmHg)

    Measured: up to 24 hours

  5. Postoperative respiratory rate (breath /minute )

    All patients will be followed up and assessed at baseline and one hour, 2 hour, 4 hour, hour, 12 hour and 24 hours for postoperative respiratory rate measurement (breath /min)

    Measured: Up to 24 hours

  6. Postoperative Nausea and Vomiting

    All patients will be followed up and assessed at baseline, one hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours, postoperative for postoperative Nausea and Vomiting (PONV) score (0=no nausea and vomiting, 1=mild nausea, 2=severe nausea, 3=vomiting once, and 4=repeated vomiting) .

    Measured: Up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start1 Dec 2022
  3. Primary completion1 Dec 2023
  4. Study completion1 May 2024

Resources

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Ultrasound guided pectoral nerve block will be performed after induction of general anaesthesia . Starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line. The needle will be inserted in plane with ultrasound probe between 2 pectoralis muscles and 10 mL of bupivacaine 0.25% alone or with ketamine or magnesium will be injected between the 2 pectoral after negative aspiration for blood (PECS I) then the ultrasound probe will be moved towards axilla until identification of the serratus anterior then the needle will be inserted between pectoralis minor and serratus anterior muscles and 20 mL of bupivacaine 0.25% alone or with ketamine or magnesium will be injected after negative aspiration. Skin incision will be performed 15 minutes after the block will be given . After extubation , all patients will be transferred to the post anesthesia care unit for postoperative monitoring and observation
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663801
Sponsor's protocol ID
PECS block in mastectomy
Status last verified
Dec 2024
First submitted
10 Nov 2022
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: all collected Individual Participant Data (IPD) that underlie results in a publication

Publications

  • Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

    PubMed 25376971

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Use of Bupivacaine in pectoral nerve block in mastectomy, use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy and Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy in people with Cancer and Breast, run by Beni-Suef 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 8 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 27 Dec 2024. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 postoperative time to first request of analgesia (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663801, which also lists 1 linked publication.

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 27 Dec 2024.

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