Analgesic Efficacy of Sequential Rapid Versus Slow Intrathecal Injection Of Dexmedetomidine Followed by of Hyperbaric Bupivacaine in Inguinal Hernia Repair Surgery
1 other identifier
interventional
50
1 country
1
Brief Summary
Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Versus Sequential Slow Injection of Both Drugs in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Feb 2024
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedMay 24, 2024
May 1, 2024
3 months
February 2, 2024
May 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of postoperative analgesia
time from reaching the sensory level of T6 until the need of first dose of rescue analgesia
24 hours
Secondary Outcomes (4)
Onset of sensory block
20 minutes
Onset of motor block using Bromage scale
30 minutes
VIisual Visual analouge scale Visual analogue scale (VAS) score at 0.5-, 1-, 2-, 4-, 6-, 8-, 10-, 12-, 18-and 24-hour post operatively
24 hrs
Total dose of postoperative pethidine
24 hours
Study Arms (2)
(Group A): rapid sequential group
ACTIVE COMPARATOR(Group B): normal sequential group
ACTIVE COMPARATORInterventions
Analgesic Efficacy of Sequential Rapid Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine Injection in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery
Analgesic Efficacy of Sequential Slow Intrathecal Injection Of Dexmedetomidine Followed by Slow Injection of Hyperbaric Bupivacaine in Patients Undergoing Unilateral Inguinal Hernia Repair Surgery
Eligibility Criteria
You may qualify if:
- patients undergoing inguinal hernia repair surgery.
- Age between 18 years and 65 years.
- Both sexes
- ASA I \& ASA II
You may not qualify if:
- Patients refusal
- Pregnant women
- Duration of surgery more than 2 hours.
- Chronic use of opioids or tranquilizers.
- Incooperative patients e.g mentally retarded.
- Patients with any contraindications to spinal anesthesia
- Allergy to the used drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy hospitals
Cairo, 11562, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of Anesthesia, pain management & surgical ICU
Study Record Dates
First Submitted
February 2, 2024
First Posted
February 12, 2024
Study Start
February 15, 2024
Primary Completion
May 20, 2024
Study Completion
May 20, 2024
Last Updated
May 24, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share