Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

Study Overview
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Brief Summary
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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.

Detailed Description
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The present study was conducted on 90 adult patients aged between 20 and 65 years old. Patients scheduled for modified radical mastectomy with axillary clearance surgery American Society of Anaesthetist (ASA) classes I, II, and III patients were included in the study. Patients were randomly allocated into on of three groups according to the adjuvant used with the local anaesthetic, 30 patients in each group using a computerised program. All patients received PECS block. Group (C) received PECS block with 0.25% bupivacaine (control group), group (A) bupivacaine with added adenosine, and group (M) bupivacaine with added magnesium sulphate. The local anaesthetic syringes were prepared by an independent anaesthetist. The researchers and the patients were blinded to the local anaesthetic adjuvant in the syringes. All patients received 30 ml local anaesthetic for PECS. The 30 ml local anaesthetic used for each patient contained bupivacaine hydrochloride 0.25%, bupivacaine hydrochloride 0.25% and 12 mg adenosine, and bupivacaine hydrochloride 0.25% and 500 mg magnesium sulphate for groups C, A, and M respectively. Patients' demographic data were collected including age, BMI, ASA, and duration of surgery. In the post- anesthetic care unit (PACU) the visual analogue score (VAS) was assessed on arrival and then every 15 minutes. The duration and the quality of the block was recorded.

Official Title
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A Comparative Study of Ultrasound Guided PECS Block Using Bupivacaine Adenosine Versus Bupivacaine Magnesium Sulphate: A Randomised Controlled Trial.

Conditions
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Breast Surgery

Intervention / Treatment
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* Drug: Bupivacaine 0.25%
* Drug: Adenosine 12mg
* Drug: Magnesium Sulphate 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for modified radical mastectomy with axillary clearance surgery ASA classes I, II, and III patients were included in the study Exclusion Criteria: 1) 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Bupivacaine 0.25% for pectoral nerve block. | Drug: Bupivacaine 0.25%<br>* Bupivacaine 0.25% for PECS block<br>* Other names: Control group;|
| Other: Adenosine<br>Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block. | Drug: Bupivacaine 0.25%<br>* Bupivacaine 0.25% for PECS block<br>* Other names: Control group;Drug: Adenosine 12mg<br>* Adenosine 12 mg for PECS block<br>* Other names: Adenosine;|
| Other: Magnesium sulphate<br>Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block. | Drug: Bupivacaine 0.25%<br>* Bupivacaine 0.25% for PECS block<br>* Other names: Control group;Drug: Magnesium Sulphate 500 mg<br>* Magnesium sulphate 500 mg for PECS block<br>* Other names: Magnesium sulphate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic requirement | The total amount of morphine (mg) consumed by patients. | First 24 hours after surgery | 
| PECS block duration. | The time from performing the block until the patient started to feel pain and the effect of the block faded. | First 24 hours after surgery | 
| Mean arterial blood pressure (mmHg) | Mean arterial blood pressure reading. | Intra-operative (from induction of anaesthesia until the patient is awake) | 
| Heart rate (beat/minute) | The number of hear beats per minute | Intra-operative(from induction of anaesthesia until the patient is awake) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pectoral nerve block, Adenosine, Magnesium sulphate