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Completed

NCT Number: NCT03344679

Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

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.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine 0.25%

Drug

Bupivacaine 0.25% for PECS block

Other names: Control group

Adenosine 12mg

Drug

Adenosine 12 mg for PECS block

Other names: Adenosine

Magnesium Sulphate 500 mg

Drug

Magnesium sulphate 500 mg for PECS block

Other names: Magnesium sulphate

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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