Comparison of Analgesic Efficacy of Dexamethasone and Dexmedetomidine as an Adjuvant to 0.375 percent Ropivacaine in Lower Thoracic Erector Spinae Plane Block for Total Laparoscopic Hysterectomy: A Prospective, Randomised, Double blind Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To assess and compare postoperative time to first tramadol request .
Study Overview
Brief Summary
This study aims to compare the analgesic efficacy of dexamethasone and dexmedetomidine as an adjuvant to 0.375% ropivacaine in lower thoracic erector spinae plane block for total laparoscopic hysterectomy.
This study will be conducted in patients undergoing anaesthesia for elective total laparoscopic hysterectomy at Jawaharlal Nehru Medical College, Ajmer, Rajasthan.
This is hospital based prospective randomised double blind study of total sample size 90 and conducted in two groups A and B (45 each), after computer generated randomisation and concealed allocation. Patients with age between 40-60 years old , belonging to ASA PS class I and II, with haemoglobin at least 9 gm/dl, and free from acute or chronic illness.
Primary objective is to assess and compare the postoperative time to opioid request.
Secondary objectives are pain score at rest and movement, total amount of opioid consumption in first 48 hours postoperatively, duration of sensory block, sedation score and any side effects noted.
In this study, total 90 patients undergoing total laparoscopic hysterectomy are allocated randomly into two groups (45 in each group ) and one group receives injection 4 mg dexamethasone mixed with injection ropivacaine and another group receives injection dexmedetomidine 0.5 mcg/Kg mixed with injection ropivacaine given bilaterally in the erector spinae plane identified under ultrasound guidance and after 15-20 mins the sensory effect is checked by pin prick method, along with the onset of sensory block.
Followed by administration of general anaesthesia and Intraoperative requirement of opioid analgesic is noted and change in hemodynamic parameters like blood pressure, mean arterial pressure, oxygen saturation by 20% above the baseline is noted.
After extubation patients are shifted to postoperative care unit, where they are monitored, opioid requirement, duration of sensory block, any side effects like nausea, vomiting, bradycardia, hypotension noted.
Data will be stored in Ms-Excel and will analyse with STATA version 14.
The results between two groups will be compared using unpaired t-test or Wilcoxan signed rank test as per the data shape.
The results were statistical significant based on p value < 0.05.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patients belonging to ASA PS class I and II.
- •Patients undergoing Total laparoscopic hysterectomy of duration 1.5-2 hours in operation theatre with haemoglobin at least 9 gm/dl.
- •Patients free from any associated acute or chronic systemic illness.
Exclusion Criteria
- •Uncooperative patients.
- •Patients with chronic pain or on long term analgesics.
- •Any known hypersensitivity or contraindication to ropivacaine.
- •Local pathology at the site of injection or disability limiting the performance of block (deformity of spine).
- •Patients receiving beta blockers or cardiac drugs .
- •History of convulsions, allergy to drugs used , bleeding disorder, severe neurological deficits, thyroid disorder.
- •Patient with a history of respiratory, cardiac, hepatic, or renal disease ( necessitating classification in ASA class III or above.
- •Patients having a history of significant neurological, psychiatric, or neuromuscular disorder.
- •Patients with deranged PT-INR .
Outcomes
Primary Outcomes
To assess and compare postoperative time to first tramadol request .
Time Frame: Baseline
Secondary Outcomes
- To assess and compare :(Visual analogue scale (VAS) score at rest and movement.)
Investigators
Dr Beena Thada
JLN MEDICAL COLLEGE, AJMER, RAJASTHAN