Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Analgesia

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pravara Institute of Medical Sciences University
ClinicalTrials.gov Identifier:
NCT01205360
First received: September 17, 2010
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Primigravida in Labour Pains.
Drug: Bupivacaine-Fentanyl Mixture
Drug: Bupivacaine-Fentanyl Mixture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Control Study to Evaluate Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Analgesia

Resource links provided by NLM:


Further study details as provided by Pravara Institute of Medical Sciences University:

Primary Outcome Measures:
  • Total epidural bupivacaine dose [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Labour analgesic drug administration will be stopped after delivery and the total dose of bupivacaine will be calculated.


Secondary Outcome Measures:
  • Demographics [ Time Frame: 10 Minutes ] [ Designated as safety issue: No ]
    Age, Height,Weight

  • Quality of analgesia (Cumulative analgesia scores ) [ Time Frame: Every Hour ] [ Designated as safety issue: No ]

    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

    1. = Awareness of pressure or tightening sensation but not painful
    2. = Slight pain or pressure sensation but not distressing
    3. = 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.

  • Level of analgesia (VAS score) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.

  • Maternal satisfaction [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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'.

  • No.of doses omitted [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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.

  • No.of Additional top-ups required [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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)

  • Duration of labour [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Labour analgesic drug administration will be stopped after delivery and the duration of labour will be recorded.

  • Maternal Safety [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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.

  • Foetal Safety [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    FHR will be monitored through tococardiography.Neonates will be assessed by Apgar score at 1 minute and 5 minutes after birth.


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine-Fentanyl (3-15)
Three millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 15 minutes as automated boluses.
Drug: Bupivacaine-Fentanyl Mixture
Three millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 15 minutes as automated boluses.
Other Name: Bupivacaine-Fentanyl
Experimental: Bupivacaine-Fentanyl (4-20)
Four millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 20 minutes.
Drug: Bupivacaine-Fentanyl Mixture
Four millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 20 minutes.
Other Name: Bupivacaine-Fentanyl
Experimental: Bupivacaine-Fentanyl (6-30)
Six millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 30 minutes.
Drug: Bupivacaine-Fentanyl Mixture
Six millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 30 minutes.
Other Name: Bupivacaine-Fentanyl

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205360

Sponsors and Collaborators
Pravara Institute of Medical Sciences University
Investigators
Principal Investigator: Dr.Mandar V Galande, MBBS Pravara Rural Hospital
Principal Investigator: Dr.Ramchandra V Shidhaye, MD DA Pravara Rural Hospital
Principal Investigator: Dr.Devdas S Divekar, MD DA Pravara Rural Hospital, Loni
  More Information

No publications provided

Responsible Party: Dr.Mandar Galande, Pravara Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01205360     History of Changes
Other Study ID Numbers: abcd 2
Study First Received: September 17, 2010
Last Updated: September 23, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Pravara Institute of Medical Sciences University:
Analgesia, labour;
Analgesic techniques, epidural;
Drug delivery, intermittent bolus;
Anesthetics local, Bupivacaine;
Analgesics opioid, Fentanyl;

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 14, 2014