COMPARISON OF CHLOROPROCAINE WITH ROPIVACAINE FOR SPINAL ANAESTHESIA IN SHORT GYNAECOLOGICAL SURGERIES
- Registration Number
- CTRI/2019/10/021521
- Lead Sponsor
- University College of Medical Sciences
- Brief Summary
Study Title: Comparison of Intrathecal Chloroprocaine and Ropivacaine in short gynaecological procedures: A Prospective randomized double blind study
Rationale: Many short procedures are routinely performed for diagnosis and treatment in gynaecology. Various techniques like simple sedation, subarachnoid block, paracervicalblock and general anaesthesia of short duration are used for minor surgeries. Patients get an advantage of short hospital stay, early recovery and low risk of infection. Spinal anaesthesia helps to achieve these goals as it offers complete analgesia, early onset, faster recovery, and better safety profile. Short acting spinal anaesthetic like chloroprocaine is preferred because of early onset and faster recovery. Isobaric ropivacaine has been used in short procedures like knee arthroscopies. There are no studies available comparing intrathecal chloroprocaine and ropivacaine for short gynaecological procedures.
AIM: To compare intrathecal 2-Chloroprocaine with Ropivacaine in short gynaecological procedures
OBJECTIVES
Primary
-To compare the duration of sensory block following administration of intrathecal isobaric Chloroprocaine and isobaric Ropivacaine
Secondary
- To compare the time of onset, maximum level of sensory block and duration of sensory block
- To compare the time of onset, intensity and duration of motor block
- Heart rate and blood pressure changes
Side effects like pruritis, respiratory depression, bradycardia, hypotension, nausea, vomiting and headache
Setting: The study will be conducted in the Department of Anaesthesiology, Critical care and Pain Medicine, University college of Medical Sciences and Guru Teg BahadurHospital
Design of study: Double blind randomized study
Duration of study: November 2018 to April 2020
Ethical clearance and consent
After getting clearance from the Institutional Ethical Committee –Human Research (IEC-HR), a written informed consent will be taken from all the patients participating in the study.
Study Design
This study will be a prospective, randomized, double blind study. Randomization will be done by a computer generated random number table. Both the observer and patient will be blinded to the drug used and a third person will prepare the study drug.
Sample size
Considering the mean and standard deviation of duration of sensory block as (105 ± 9.83) minutes and (132 ± 38) minutes in chloroprocaine group and ropivacaine group respectively from previous studies. To estimate the difference of 27 minutes, sample size of 23 cases is required in each group for sensory block at alpha =5% and power 80%.
Considering a duration of 110±35 minutes for ropivacaine and 75±5.7 minutes for chloroprocaine for duration of motor block. Eleven cases are required in each group.
We will be studying 25 patients in each group.
Selection of cases:
50 patients fulfilling inclusion criteria will be randomly allocated to 2 groups with sample size of 25 in each group using computer generated random number table.
Inclusion criteria
- Patients belonging to ASA I and ASA II undergoing short duration gynaecological procedures lasting up to 1 hour approximately
- Patients between the age of 18-60 years
- Patients with height of >150 cms and <180 cms
Exclusion criteria
- Patients with contraindication to subarachnoid block
- Patients allergic to drugs used in this study
- Patients with BMI more than 30 kg/m2
- Patients on long term opioid use
- Patients with history of chronic pain
-Patients with significant pre existing severe systemic illness like cardiovascular, central nervous system and hepatorenal diseases
- Patients not willing to participate in the study
Methods: under all aseptic precautions subarachnoid block will be given to the patient in sitting position in L3-L4 intervertebral space. Patient will receive the study drug intrathecally according to the group allocated:
Group C: 40 mg of 1% isobaric chloroprocaine (4 ml)
Group R: 8 mg of 0.5% isobaric ropivacaine (1.6ml)
Block characteristics will be assessed using loss of pin-prick method for sensory block and Modified Bromage Scale for motor block. Hemodynamic parameters will be also recorded.
Primary outcome: Duration of sensory block
Secondary outcome: Time of onset, maximum level of sensory block and duration of sensory block, time of onset, and duration of motor block, heart rate and blood pressure changes, side effects like pruritis, respiratory depression, bradycardia, hypotension, nausea, vomiting and headache.
Statistical analysis :
Quantitative parameters will be compared using unpaired t-test if data found normal, otherwise Mann Whitney U test will be done.
Qualitative parameters will be compared using chi-square test.
Hemodynamic parameters will be compared by repeated measure ANOVA followed by Dunnett’s test.
P value <0.05 will be considered significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 50
Patients belonging to ASA I and ASA II undergoing short duration gynaecological procedures lasting up to 1 hour approximately Patients with height of >150 cms and <180 cms.
Patients with contraindication to subarachnoid block Patients allergic to drugs used in this study Patients with BMI more than 30 kg/m2 Patients on long term opioid use Patients with history of chronic pain Patients with significant pre existing severe systemic illness like cardiovascular, central nervous system and hepatorenal diseases Patients not willing to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the duration of sensory block following administration of intrathecal isobaric Chloroprocaine and isobaric Ropivacaine 0,1,2,3,4,5,6,7,8,9,10,12,14, 16,18,20,30,40,50,60 min after subarachnoid block | 0,0.5,1,1.5,2,2.5,3,3.5,4, 4.5,5hrs in postoperative period
- Secondary Outcome Measures
Name Time Method To compare the time of onset, intensity and duration of motor block 0,1,2,3,4,5,6,7,8,9,10,12,14, 16,18,20,30,40,50,60 min after subarachnoid block To compare the time of onset, maximum level of sensory block and duration of sensory blockade 0,1,2,3,4,5,6,7,8,9,10,12,14, 16,18,20,30,40,50,60 min after subarachnoid block Hemodynamic parameters 0,2,5,10,15,20,25,30,35,40,45,50,55,60 min after subarachnoid block
Trial Locations
- Locations (1)
UCMS and GTB Hospital
🇮🇳East, DELHI, India
UCMS and GTB Hospital🇮🇳East, DELHI, IndiaDr Sujata ChaudharyPrincipal investigator9999051546sujatac462@gmail.com