(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: Q519||Congenital malformation of uterusand cervix, unspecified, (3) ICD-10 Condition: N750||Cyst of Bartholins gland, (4) ICD-10 Condition: N86||Erosion and ectropion of cervix uteri, (5) ICD-10 Condition: N979||Female infertility, unspecified, (6) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified, (7) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, (8) ICD-10 Condition: N84||Polyp of female genital tract, (9) ICD-10 Condition: N849||Polyp of female genital tract, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
40 mg of 1% isobaric Chloroprocaine(4ml)
Drug will be administered via subarachnoid route only once in procedures lasting approximately 1 hour and the block characteristics will be noted
Comparator Agent
8 mg of 0.5% isobaric Ropivacaine(1.6 ml)
Drug will be administered via subarachnoid route only once in procedures lasting approximately 1 hour and the block characteristics will be noted.
Intervention
Subarachnoid block
Subarachnoid block will be given in sitting position in L3-L4 intervertebral space and block characteristics and haemodynamic variables will be recorded.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Female
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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
0,0.5,1,1.5,2,2.5,3,3.5,4, 4.5,5hrs in postoperative period
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
0,0.5,1,1.5,2,2.5,3,3.5,4, 4.5,5hrs in postoperative period
Hemodynamic parameters
0,2,5,10,15,20,25,30,35,40,45,50,55,60 min after subarachnoid block
0,0.5,1,1.5,2,2.5,3,3.5,4, 4.5,5hrs in postoperative period
Target Sample Size
Total Sample Size="50" Sample Size from India="50" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
04/10/2019
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Study Title:Comparison of IntrathecalChloroprocaine and Ropivacaine in short gynaecological procedures: A Prospective randomized double blind study
Rationale:Manyshort proceduresare 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 thesegoalsas it offers complete analgesia, early onset, faster recovery, and better safety profile. Short acting spinal anaesthetic like chloroprocaine is preferredbecause of early onset and faster recovery. Isobaric ropivacaine has been used in short procedures like knee arthroscopies.There are no studies available comparing intrathecalchloroprocaine and ropivacaine for short gynaecological procedures.
AIM: Tocompare 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
- Tocompare 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 TegBahadurHospital
Design of study: Double blind randomized study
Duration of study:November2018 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 of27 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±5.7minutes 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 betweenthe age of18-60 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 andhepatorenal 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.