Bupivacaine Alone vs Bupivacaine and Dexmed in Cesarean Deliveries
Comparison of Effects of Intrathecal Hyperbaric Bupivacaine Alone Versus Hyperbaric Bupivacaine Combined With Dexmedetomidine in Cesarean Section Deliveries
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of the study is to compare the onset and duration of sensory and motor block after spinal anesthesia between intrathecal bupivacaine alone vs intrathecal bupivacaine and dexmedetomidine combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2022
CompletedFirst Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedJuly 21, 2022
July 1, 2022
5 months
June 30, 2022
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Onset of Sensory Block
Mean time to loss of sensation to pin prick using a 27 G blunt needle at the level of the xiphoid (T6) from the time of injection of drug intrathecally.
8 mins
Onset of Motor Block
Mean time taken to reach Bromage Score I from the time of injection of drug intrathecally
8 mins
Duration of Sensory Block
Mean time from spinal injection to the 1st request for analgesics or VAS ≥ 4; whichever comes first.
8 hours
Duration of Motor Block
Mean time from spinal injection to regaining of Bromage score 4
8 hours
Study Arms (2)
Bupivacaine
NO INTERVENTIONParticipants to be given 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries.
Bupivacaine + Dexmedetomidine
ACTIVE COMPARATORParticipants to be given 5mcg dexmedetomidine in addition to 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries.
Interventions
5mcg dexmedetomidine to be given intrathecally along with 0.5% bupivacaine.
Eligibility Criteria
You may qualify if:
- Pregnant females of age 18-45 years
- ASA physical status II
- Body Mass Index (BMI) of 18-35 kg/m2
You may not qualify if:
- Any relative or absolute contra-indication to spinal anesthesia
- Allergy to dexmedetomidine
- Subjects with pre-existing non-obstetric medical co-morbidities
- Patient refusal for spinal technique
- Obstetrics emergencies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KRL Hospital
Islamabad, 44000, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rida Qureshi
KRL Hospital, Islamabad
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Anaesthesia
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 21, 2022
Study Start
April 15, 2022
Primary Completion
September 15, 2022
Study Completion
October 15, 2022
Last Updated
July 21, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share