Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

Breast Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344679
• Other study ID #: MenoufiaU2015
• Status: Completed
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 13, 2017
• Start date: February 1, 2015
• Est. completion date: July 22, 2017

Study information

• Verified date: November 2017
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 22, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Surgery

Intervention

Drug:
• Bupivacaine 0.25%
Bupivacaine 0.25% for PECS block
• Adenosine 12mg
Adenosine 12 mg for PECS block
• Magnesium Sulphate 500 mg
Magnesium sulphate 500 mg for PECS block

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic requirement	The total amount of morphine (mg) consumed by patients.	First 24 hours after surgery
Secondary	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
Secondary	Mean arterial blood pressure (mmHg)	Mean arterial blood pressure reading.	Intra-operative (from induction of anaesthesia until the patient is awake)
Secondary	Heart rate (beat/minute)	The number of hear beats per minute	Intra-operative(from induction of anaesthesia until the patient is awake)