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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05663801
• Other study ID #: PECS block in mastectomy
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: Beni-Suef University
• Contact: Doaa M Sayem, lecturer
• Phone: 0201145535452
• Email: doaamoazsayem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 these drugs has the more effective analgesic effect and decrease opioid consumption .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female patient

• Age from 30 to 70 years old

• American Society of Anesthesiologists (ASA) I-II

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast
• Cancer

Intervention

Drug:
• Use of Bupivacaine in pectoral nerve block in mastectomy
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 mastectomy
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 mastectomy
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

Locations

Country	Name	City	State
Egypt	faculty of medicine ,Beni-Suef university	Bani Suwayf	Beni-Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 hours
Secondary	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 )	up to 24 hours
Secondary	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)	up to 24 hours
Secondary	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)	up to 24 hours
Secondary	Postoperative non-invasive 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)	up to 24 hours
Secondary	Postoperative respiratory rate (breath/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 respiratory rate measurement in (breath/minute)	up to 24 hours
Secondary	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) .	up to 24 hours

External Links

•   Pectoral Nerves Blocks for Post-Operative Analgesia after Breast Cancer Surgery