Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

NCT03344679 | Completed

• 1 other identifier: MenoufiaU2015
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Breast Surgery

Keywords

Pectoral nerve block; Adenosine; Magnesium sulphate

Outcome Measures

Primary Outcomes (1)

• 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.

  First 24 hours after surgery

Secondary Outcomes (4)

• Analgesic requirement

  First 24 hours after surgery

• PECS block duration.

  First 24 hours after surgery

• Mean arterial blood pressure (mmHg)

  Intra-operative (from induction of anaesthesia until the patient is awake)

• Heart rate (beat/minute)

  Intra-operative(from induction of anaesthesia until the patient is awake)

Study Arms (3)

Control group

OTHER

Bupivacaine 0.25% for pectoral nerve block.

Drug: Bupivacaine 0.25%

Adenosine

OTHER

Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block.

Drug: Bupivacaine 0.25%; Drug: Adenosine 12mg

Magnesium sulphate

OTHER

Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block.

Drug: Bupivacaine 0.25%; Drug: Magnesium Sulphate 500 mg

Interventions

Bupivacaine 0.25% DRUG

Bupivacaine 0.25% for PECS block

Also known as: Control group

Adenosine; Control group; Magnesium sulphate

Adenosine 12mg DRUG

Adenosine 12 mg for PECS block

Also known as: Adenosine

Adenosine

Magnesium Sulphate 500 mg DRUG

Magnesium sulphate 500 mg for PECS block

Also known as: Magnesium sulphate

Magnesium sulphate

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for modified radical mastectomy with axillary clearance surgery ASA classes I, II, and III patients were included in the study

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Interventions

Control Groups; Adenosine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2015
• Primary Completion: June 15, 2017
• Study Completion: July 22, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share