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

NCT05663801 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PECS block in mastectomy
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Cancer; Breast

Keywords

Magnesium sulphate; ketamine; PECS block; Mastectomy

Outcome Measures

Primary Outcomes (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

  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 .

  up to 24 hours

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

  up to 24 hours

• Postoperative heart rate (Beat/minute)

  up to 24 hours

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

  up to 24 hours

• Postoperative respiratory rate (breath /minute )

  Up to 24 hours

Study Arms (3)

Group A (control group )

ACTIVE COMPARATOR

Patients will be given 30 mL of 0.25% bupivacaine hydrochloride in pectoral nerve block .

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 .

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

Drug: Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy

Interventions

Use of Bupivacaine in pectoral nerve block in mastectomy DRUG

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

Also known as: marcain

Group A (control group )

use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy DRUG

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

Also known as: ketalar

Group B ( Ketamine group)

Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy DRUG

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

Also known as: Mgso4

Group C (Magnesium sulfate group)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

faculty of medicine ,Beni-Suef university

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Related 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.

  PMID: 25376971 RESULT

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

Mastectomy; Bupivacaine; Ketamine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Doaa M Khalil, lecturer

  Research Ethical Committee,faculty of medicine Beni-Suef university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: this is a randomized double-blinded study All patients included will be divided randomly into three groups Preoperative data will be recorded by anesthesiologist who will be blinded to the study . The studied drugs will be prepared by anesthetist ( who will be blinded to the study and will not involved in the technique) in labeled syringes . Randomization will be done using a computer-generated sequence. The randomly assigned numbers in each group will be hidden in sealed and opaque envelopes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anaesthesia, Department of anaesthesia, Surgical Intensive Care Unit and Pain Management Faculty of Medicine ,Beni-Suef university

Model Details: 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

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 23, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: the data will be available within 10 months
• Access Criteria: individual participant data will be shared as study protocol and statistical analysis in web site

Locations

EG (1)