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Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

NCT ID: NCT03344679

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2017-07-22

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.

Conditions

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Breast Surgery

Keywords

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Pectoral nerve block Adenosine Magnesium sulphate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Bupivacaine 0.25% for pectoral nerve block.

Group Type OTHER

Bupivacaine 0.25%

Intervention Type DRUG

Bupivacaine 0.25% for PECS block

Adenosine

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

Group Type OTHER

Bupivacaine 0.25%

Intervention Type DRUG

Bupivacaine 0.25% for PECS block

Adenosine 12mg

Intervention Type DRUG

Adenosine 12 mg for PECS block

Magnesium sulphate

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

Group Type OTHER

Bupivacaine 0.25%

Intervention Type DRUG

Bupivacaine 0.25% for PECS block

Magnesium Sulphate 500 mg

Intervention Type DRUG

Magnesium sulphate 500 mg for PECS block

Interventions

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Bupivacaine 0.25%

Bupivacaine 0.25% for PECS block

Intervention Type DRUG

Adenosine 12mg

Adenosine 12 mg for PECS block

Intervention Type DRUG

Magnesium Sulphate 500 mg

Magnesium sulphate 500 mg for PECS block

Intervention Type DRUG

Other Intervention Names

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Control group Adenosine Magnesium sulphate

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Dr Ezzeldin Ibrahim

Assistant Professor in anaesthesia, intensive care, and pain medicine.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MenoufiaU2015

Identifier Type: -

Identifier Source: org_study_id