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Trial record 10 of 1176 for:    adenosine

Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

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ClinicalTrials.gov Identifier: NCT03344679
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Ezzeldin Ibrahim, Menoufia University

Tracking Information
First Submitted Date  ICMJE November 9, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE February 1, 2015
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Analgesic requirement [ Time Frame: First 24 hours after surgery ]
    The total amount of morphine (mg) consumed by patients.
  • 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.
  • Mean arterial blood pressure (mmHg) [ Time Frame: Intra-operative (from induction of anaesthesia until the patient is awake) ]
    Mean arterial blood pressure reading.
  • Heart rate (beat/minute) [ Time Frame: Intra-operative(from induction of anaesthesia until the patient is awake) ]
    The number of hear beats per minute
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.
Official Title  ICMJE A Comparative Study of Ultrasound Guided PECS Block Using Bupivacaine Adenosine Versus Bupivacaine Magnesium Sulphate: A Randomised Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Breast Surgery
Intervention  ICMJE
  • Drug: Bupivacaine 0.25%
    Bupivacaine 0.25% for PECS block
    Other Name: Control group
  • Drug: Adenosine 12mg
    Adenosine 12 mg for PECS block
    Other Name: Adenosine
  • Drug: Magnesium Sulphate 500 mg
    Magnesium sulphate 500 mg for PECS block
    Other Name: Magnesium sulphate
Study Arms  ICMJE
  • Control group
    Bupivacaine 0.25% for pectoral nerve block.
    Intervention: Drug: Bupivacaine 0.25%
  • Adenosine
    Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block.
    Interventions:
    • Drug: Bupivacaine 0.25%
    • Drug: Adenosine 12mg
  • Magnesium sulphate
    Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block.
    Interventions:
    • Drug: Bupivacaine 0.25%
    • Drug: Magnesium Sulphate 500 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2017)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 22, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03344679
Other Study ID Numbers  ICMJE MenoufiaU2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Ezzeldin Ibrahim, Menoufia University
Study Sponsor  ICMJE Menoufia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Menoufia University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP