Comparing pain relief between dexmedetomidine and dexamethasone with ropivacaine after costotransverse block in patients undergoing breast surgeries.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/04/051463
- Lead Sponsor
- Department of Anaesthesia and Intensive care
- Brief Summary
Breast surgery is one of the most commonly performed surgery in women. With the recently introduced Costotransverse block (CTB), this study is designed to establish the postoperative analgesic efficacy of single shot CTB by adding either dexmedetomidine or dexamethasone as adjuvant with ropivacaine.
30 patients will be allocated into each group.
Intervention group 1 (Group CTB-SONE): Patients will receive single shot costotransverse block with 15 ml of 0.75%ropivacaine with 0.1mg/kg dexamethasone to make total volume of 18ml.
Intervention group 2 (Group CTB-DINE): Patients will receive single shot costotransverse block with 15ml of 0.75%ropivacainewith dexmedetomidine 1 mcg/kg to make total volume of 18ml.
On the day of surgery, an intravenous (IV) line will be started at 2ml/kg through 20 G cannula.
Basic monitoring including electrocardiogram, peripheral oxygen saturation (spo2), non-invasive blood pressure (NIBP), heart rate (HR) and capnography (after intubation) will be done.
The block will be given after the induction of anaesthesia and before the start of the surgical procedure.
The same general anaesthesia plan will be applied to all patients in both groups.
Tyhe patient will be induced with propofol (2-3mg/kg), fentanyl (1.5-2ug/kg) followed by vecuronium bromide (0.1ug/kg) to facilitate endotracheal intubatuion.
Anaesthesia will be maintained with oxygen, nitrous oxide, sevoflurane (0.6-1 MAC) or propofol infusion (50-150 ug/kg/min).
The patients’s HR, NIBP, SpO2 will be recorded before the block, at the time of block and every 5 min up to 30 min after the block.
All the patients will be reversed and after extubation will be shifted to the post-operative anaesthesia care unit and monitored for 2 h, after which patient will be shifted to ward and will be monitored upto 24 h postoperatively.
The primary outcome measure of the study is to determine the quality of recovery, assessed using the Quality of Recovery (QoR-15) scale at 24 h post operatively.
The time from institution of block to the time for the first analgesic request in the post-opeartive period will be recorded.
the pain score on a VAS at rest and on arm movement will be monitored and the patient satisfaction and future willingness to undergo repeat peripheral nerve block will also be recorded at regular intervals for a period of 24 h.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Female
- Target Recruitment
- 60
American Society of Anesthesiologists (ASA) class I-II Age more than 18 years at the date of inclusion Females posted for breast surgery Who have received thorough information and have signed the informed written consent form.
- Patient refusal ASA III- IV including patient with severe respiratory,cardiovascular, liver and metabolic or pre-existing neurological deficit Skin infection at puncture site Allergy to study drugs Recent history of use of analgesic/steroid drugs Pregnant patient History of psychiatric illness and substance abuse.
- Morbid obesity BMI >40 kg/m2 Coagulation abnormalities (INR>1.5,thrombocytopenia).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of dexmedetomidine At 24 hrs. versus dexamethasone as an adjuvant to At 24 hrs. ropivacaine on pain relief after costotransverse At 24 hrs. block by determining the quality of recovery assessed using Quality of Recovery(QoR-15) scale at 24 hour post operatively. At 24 hrs.
- Secondary Outcome Measures
Name Time Method To determine the time for first requirement of analgsia. Total cumulative dose of rescue analgesic
Trial Locations
- Locations (1)
Government Medical College and Hospital, Sector 32B, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Government Medical College and Hospital, Sector 32B, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Geetanshu GuptaPrincipal investigator9946643043dr.geetanshugupta@gmail.com