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Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03344679
Enrollment
90
Registered
2017-11-17
Start date
2015-02-01
Completion date
2017-07-22
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Surgery

Keywords

Pectoral nerve block, Adenosine, Magnesium sulphate

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.

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.

Interventions

DRUGBupivacaine 0.25%

Bupivacaine 0.25% for PECS block

DRUGAdenosine 12mg

Adenosine 12 mg for PECS block

Magnesium sulphate 500 mg for PECS block

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale (VAS)First 24 hours after surgeryVisual analogue scale is a scale from 1 to 10 where 1 is no pain and 10 is the worst pain the patient experienced.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026