Primigravida in Labour Pains Clinical Trial
Official title:
A Randomized, Control Study to Evaluate Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Analgesia
Verified date | September 2010 |
Source | Pravara Institute of Medical Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine how manipulation of the programmed intermittent time interval and volume influences total drug use, quality of analgesia, and patient satisfaction during maintenance of labor analgesia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Full term women in spontaneous labor. - Gestation greater than or equal to 37 weeks. - Primigravida. - Age group between 18 Years to 45 Years. - ASA grade I or II - Not having any complicated pregnancy - Not having any systemic disorders. Exclusion Criteria: - Not willing for Epidural analgesia. - Unwilling to get enrolled in this study. - Systemic disorder like diabetes mellitus, hypertension and heart disease, spine deformity, blood coagulation disorder, bad obstetric history and foetal abnormity. - Multiple-pregnancy or abnormal presentation. - Complicated pregnancy like pregnancy induced hypertension, placenta previa, abruptio placenta. - Cervical dilatation less than 2 or greater than 5 at time of initiation of neuraxial analgesia. - Chronic analgesic medications - Systemic opioid labor analgesia prior to the initiation of neuraxial labor analgesia. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pravara Institute of Medical Sciences University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total epidural bupivacaine dose | Labour analgesic drug administration will be stopped after delivery and the total dose of bupivacaine will be calculated. | 48 hours | |
Secondary | Demographics | Age, Height,Weight | 10 Minutes | |
Secondary | Quality of analgesia (Cumulative analgesia scores ) | The quality of analgesia will be assessed hourly. The patients will be asked about pain relief during the last hour and will be given scores as follows: 0 = No pain, pressure or tightening sensation = Awareness of pressure or tightening sensation but not painful = Slight pain or pressure sensation but not distressing = Distressing pain or pressure sensation Even when the patients scored higher for a very short period, the higher score will be recorded for that hour. Cumulative analgesia scores will be measured. |
Every Hour | |
Secondary | Level of analgesia (VAS score) | All patients will be interviewed within 24 hours of delivery by an anaesthetist colleague who will unaware of the technique used and recorded a linear visual analogue scale (VAS) pain score on the patient's opinion about overall efficacy of analgesia. On this scale, 0 cm will indicate no pain and 10 cm will indicate worst pain. | 48 hours | |
Secondary | Maternal satisfaction | All the patients will be interviewed within 24 hours of delivery by an anaesthetist colleague who will unaware of the technique used and They will also ask about the level of their satisfaction regarding the quality of analgesia, which will be graded as 'excellent', 'good' and 'bad'. | 48 hours | |
Secondary | No.of doses omitted | A single dose will be omitted if the sensory block goes higher than T7 or the motor blockade goes below score 4 as per the Bromage scale. | 48 hours | |
Secondary | No.of Additional top-ups required | Additional top-ups of 3 ml of 0.125 % bupivacaine with fentanyl 2 micrograms / ml will be administered if patients get severe break through pain (VAS pain score > 3) | 48 hours | |
Secondary | Duration of labour | Labour analgesic drug administration will be stopped after delivery and the duration of labour will be recorded. | 48 hours | |
Secondary | Maternal Safety | Maternal parameters like pulse rate, blood pressure and respiratory rate will be monitored frequently.The patients will be observed for any side effects or complications, such as pruritus, nausea and vomiting, hypotension, a headache, sedation and respiratory depression. | 48 hours | |
Secondary | Foetal Safety | FHR will be monitored through tococardiography.Neonates will be assessed by Apgar score at 1 minute and 5 minutes after birth. | 48 hours |