Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

November 13, 2017 updated by: Dr Ezzeldin Ibrahim, Menoufia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Bupivacaine 0.25% for pectoral nerve block.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% for PECS block
Other Names:
  • Control group
Other: Adenosine
Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% for PECS block
Other Names:
  • Control group
Drug: Adenosine 12mg
Adenosine 12 mg for PECS block
Other Names:
  • Adenosine
Other: 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 Names:
  • Control group
Drug: Magnesium Sulphate 500 mg
Magnesium sulphate 500 mg for PECS block
Other Names:
  • Magnesium sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

July 22, 2017

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MenoufiaU2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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