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.
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
- 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
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 .
- 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 group | Role | What they receive |
|---|---|---|
| Group A (control group ) | Active comparator | Patients 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 comparator | Patients 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 comparator | Patients 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.
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)
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
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
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
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
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
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.
- First posted23 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 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)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Moaz Sayem,MD, Beni-Suef University
- Investigators
- Doaa M Khalil, lecturer, Study director, Research Ethical Committee,faculty of medicine Beni-Suef university
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05663801
- Acronym / sponsor ID
- PECS block in mastectomy
- Keywords
- Magnesium sulphate, ketamine, PECS block, Mastectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 23 Dec 2022 (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.
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 .
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A (control group ) | Active comparator | Drug: Use of Bupivacaine in pectoral nerve block in mastectomyPatients will be given 30 mL of 0.25% bupivacaine hydrochloride in pectoral nerve block . |
| Group B ( Ketamine group) | Active comparator | Drug: use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomyPatients will be given 30 mL of 0.25% bupivacaine hydrochloride plus ketamine hydrochloride (1 mg/kg) in pectoral nerve block . |
| Group C (Magnesium sulfate group) | Active comparator | Drug: Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomyPatients 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patient
- Age from 30 to 70 years old
- American Society of Anesthesiologists (ASA) I-II
Key exclusion criteria (8 listed)
- Cognitive impairment
- History of alcohol or drug abuse
- Allergy to the studied drugs
- Patients with coagulation disorders
- Block site infection
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 |
|---|---|---|
| Use of Bupivacaine in pectoral nerve block in mastectomyAlso: marcainPectoral 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 | Drug | Group A (control group ) |
| use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomyAlso: ketalarPectoral 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 | Drug | Group B ( Ketamine group) |
| Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomyAlso: Mgso4Pectoral 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 | Drug | Group C (Magnesium sulfate group) |
Primary outcome
The postoperative time to first request of analgesia
Time frame: up to 24 hours
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
6 secondary outcomes
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 .
Time frame: up to 24 hours
Postoperative analgesic requirements( (pethidine in milligram/ kilogram (mg/kg) )
Time frame: up to 24 hours
Postoperative heart rate (Beat/minute)
Time frame: up to 24 hours
Postoperative non invasive mean arterial blood pressure in millimeters of mercury (mmHg)
Time frame: up to 24 hours
Postoperative respiratory rate (breath /minute )
Time frame: Up to 24 hours
Postoperative Nausea and Vomiting
Time frame: Up to 24 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 27 Dec 2024.
- Results publication: PubMed 25376971Bashandy 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.
- Pectoral Nerves Blocks for Post-Operative Analgesia after Breast Cancer SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected Individual Participant Data (IPD) that underlie results in a publication
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian 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.
Doaa M Khalil, lecturer study director
Research Ethical Committee,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 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.