EFFICACY AND SAFETY OF ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK IN REDUCING POST-OPERATIVE OPIODS REQUIREMENT IN PATIENTS UNDERGOING MASTECTOMY- A RANDOMIZED CONTROL TRIAL STUDY
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- JLN Medical college
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Duration of Analgesia
Overview
Brief Summary
With due approval from institutional ethical committee, the study will be conducted at Jawahar Lal Nehru Medical College, Ajmer, Rajasthan on patients undergoing mastectomies under general anaesthesia. This hospital based prospective randomized controlled clinical trial study is designed to include 60 female patients divided into 2 groups randomly. A written informed consent will be taken in prior to procedure. Participants will be followed and monitored for duration of analgesia at specified intervals till they complain of pain in post-operative period then the study will be terminated. Data will be collected and analysed using standard qualitative and quantitative tests. A p value of less than 0.05 will be considered as significant
Patients meeting the inclusion criteria during the pre-anaesthetic evaluation will be approached for consent, once the consent has been sought patients will be randomly assigned using computer generated tables into two groups of 30 patients each. Group A and Group B Group A – In this group, patient is taken into procedure room after verifying consent & NBM status and after being positioned supine and i.v access is secured after connecting to a cardiac monitor, vitals are measured. Ultrasound guided serratus anterior plane block will be performed in the mid axillary line at the level of 5 th rib with a 10 – 12 MHz transducer probe. Under aseptic precautions skin will be infiltrated with 2-3ml of 2% lignocaine with a 26 g h1/2 inch hypodermic needle. The block will be performed in plane to the ultrasound beam with a 22G, Quincke spinal needle. A total volume of 30 ml of 0.2 % ropivacaine will be given in the plane between Serratus Anterior muscle and latissimus dorsi muscle prior to shifting to operation theatre and induction of anaesthesia. Group B : Group B will be the control group. The patients in this group will receive intravenous Tramadol for pain relief in the post operative period
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA 1 AND ASA
- •60 years of female sex.
- •Weighing between 40 and 75 kgs. Undergoing mastectomies under general anesthesia will be included in the stud.
Exclusion Criteria
- •Ineligible to provide informed consent
- •Younger than 20 years or older than 60 years of age.
- •Impaired kidney or renal functions history of alcohol or drug abuse.
- •History of chronic pain condition or daily intake of analgesics and corticosteriods.
- •Uncontrolled systemic disease (DM, HTN)
- •Pregnant or lactating.
- •Any condition in which some drugs are contraindicated and hypersensitivity.
Outcomes
Primary Outcomes
Duration of Analgesia
Time Frame: To assess the duration of analgesia from time of extubation to demand | of first dose of rescue analgesic.
Secondary Outcomes
- 1. Total postoperative analgesic consumption.(2. Haemodynamic variables like HR, SBP, DBP, MBP, SPO2 intra)
Investigators
Pandu Ranga Rao Bangaru
JLN Medical college, Ajmer, Rajasthan