Comparison of two drugs bupivacaine and ropivacaine given in spinal anesthesia in patients undergoing surgery vaginal hysterectomy.
- Conditions
- Inflammatory disease of cervix uteri,
- Registration Number
- CTRI/2023/06/053746
- Lead Sponsor
- Dr RPGMC Kangra
- Brief Summary
Spinal anesthesia is a very old and popular technique. It is a safe and effective form of regional anesthesia that can be used as an alternative to general anesthesia in surgery. Vaginal hysterectomy is one such lower abdominal surgery which commonly involves the use of spinal anesthesia. Thus, in order to further improve and understand the safety issues as well as clinical use of spinal anesthesia in vaginal hysterectomies, new local anesthetics are being investigated for different applications.
Ropivacaine is relatively new aminoamide local anesthetic agent similar in chemical structure to Bupivacaine and has been little studied in that application. Early evaluation of the drug included few studies which stated cardiotoxicity and CNS toxicity of Ropivacaine is less as compared to Bupivacaine. But the potency of Ropivacaine is less than Bupivacaine therefore its duration and intensity will also be proportionately less as experimented in lower limb surgeries.
Considering that relatively few studies have been conducted to compare the potency and toxicity of hyperbaric Ropivacaine with hyperbaric Bupivacaine in lower abdominal surgeries, we planned to conduct a study comprising Ropivacaine 0.75% hyperbaric with Bupivacaine 0.5% hyperbaric in patients undergoing vaginal hysterectomy under subarachnoid blockade.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 60
ASA 1 & 2 BMI (18-29.9) UNDERGOING ELECTIVE VAGINAL HYSTERECTOMY WITH AN ANTICIPATED DURATION OF 120 MINUTES.
REFUSAL TO PARTICIPATE IN STUDY ALLERGY TO STUDY DRUG OBESITY (BMI>30) HEIGHT <150CM OR >180CM PATIENTS IN WHICH SPACE OTHER THAN L3-L4 WAS USED FOR SUBARACHNOID BLOCK PATIENTS WITH ABSOLUTE CONTRAINDICATIONS TO SPINAL ANAESTHESIA.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the block characteristics among two groups (sensory, motor and duration of analgesia Time of injection of spinal drug(0 min) | Time of onset of sensory block(T12) | Time to achieve peak sensory block | Peak sensory level | Max sensory level after 20 min | Two segment regression time | Duration of sensory block | Total duration of analgesia | Onset of motor block (MBS 1) | Time to achieve complete motor block (MBS 3) | Max bromage score achieved | Duration of motor block | Hemodynamic variables at 5 min interval initially and then 15 min interval til the end of surgery To study hemodynamic parameters among two groups(PR, SBP, DBP, MAP) Time of injection of spinal drug(0 min) | Time of onset of sensory block(T12) | Time to achieve peak sensory block | Peak sensory level | Max sensory level after 20 min | Two segment regression time | Duration of sensory block | Total duration of analgesia | Onset of motor block (MBS 1) | Time to achieve complete motor block (MBS 3) | Max bromage score achieved | Duration of motor block | Hemodynamic variables at 5 min interval initially and then 15 min interval til the end of surgery
- Secondary Outcome Measures
Name Time Method Any adverse events (hypotension, bradycardia, nausea and vomiting) Total duration of surgery
Trial Locations
- Locations (1)
Dr RPGMC Kangra at Tanda (H.P.)
🇮🇳Kangra, HIMACHAL PRADESH, India
Dr RPGMC Kangra at Tanda (H.P.)🇮🇳Kangra, HIMACHAL PRADESH, IndiaIshita KatnaPrincipal investigator9805292604ikatna646@gmail.com