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Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

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ClinicalTrials.gov Identifier: NCT03344679
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Ezzeldin Ibrahim, Menoufia University

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.

Condition or disease Intervention/treatment Phase
Breast Surgery Drug: Bupivacaine 0.25% Drug: Adenosine 12mg Drug: Magnesium Sulphate 500 mg Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Comparative Study of Ultrasound Guided PECS Block Using Bupivacaine Adenosine Versus Bupivacaine Magnesium Sulphate: A Randomised Controlled Trial.
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : July 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control group
Bupivacaine 0.25% for pectoral nerve block.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% for PECS block
Other Name: Control group

Adenosine
Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% for PECS block
Other Name: Control group

Drug: Adenosine 12mg
Adenosine 12 mg for PECS block
Other Name: Adenosine

Magnesium sulphate
Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% for PECS block
Other Name: Control group

Drug: Magnesium Sulphate 500 mg
Magnesium sulphate 500 mg for PECS block
Other Name: Magnesium sulphate




Primary Outcome Measures :
  1. Visual analogue scale (VAS) [ Time Frame: First 24 hours after surgery ]
    Visual analogue scale is a scale from 1 to 10 where 1 is no pain and 10 is the worst pain the patient experienced.


Secondary Outcome Measures :
  1. Analgesic requirement [ Time Frame: First 24 hours after surgery ]
    The total amount of morphine (mg) consumed by patients.

  2. PECS block duration. [ Time Frame: First 24 hours after surgery ]
    The time from performing the block until the patient started to feel pain and the effect of the block faded.

  3. Mean arterial blood pressure (mmHg) [ Time Frame: Intra-operative (from induction of anaesthesia until the patient is awake) ]
    Mean arterial blood pressure reading.

  4. Heart rate (beat/minute) [ Time Frame: Intra-operative(from induction of anaesthesia until the patient is awake) ]
    The number of hear beats per minute



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University
ClinicalTrials.gov Identifier: NCT03344679     History of Changes
Other Study ID Numbers: MenoufiaU2015
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ezzeldin Ibrahim, Menoufia University:
Pectoral nerve block
Adenosine
Magnesium sulphate
Additional relevant MeSH terms:
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Magnesium Sulfate
Adenosine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents