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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03035617 |
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Date of registration:
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25/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Evaluate Reduction in Pain After Laparoscopic Hernia Repair With Mesh Soaked in Bupivacaine Solution
HAPPIEST |
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Scientific title:
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Post-Operative Pain After Laparoscopic Ventral Hernia Repair, Impact of Mesh Impregnation With Bupivacaine Solution vs. Normal Saline Solution |
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Date of first enrolment:
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November 15, 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03035617 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Noman Shahzad, FCPS |
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Address:
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Telephone:
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+923008833313 |
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Email:
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drns01@hotmail.com |
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Affiliation:
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Name:
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Noman Shahzad, FCPS |
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Address:
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Telephone:
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+923008833313 |
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Email:
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drns01@hotmail.com |
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Affiliation:
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Name:
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Tabish U Chawla, FRCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan University Hospital Karachi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients of age > 16 Years
- Both males and females
- Ventral Abdominal Wall Hernial Defect planned to undergo laparoscopic repair.
- Ventral Abdominal Wall Hernia is defined as defect in anterior abdominal wall through
which contents of abdominal cavity can protrude. Anterior abdominal wall extends from
Xiphisternum above to symphysis pubis below and anterior axillary lines laterally.
- We plan to include both primary and incisional hernias in our study.
Exclusion Criteria:
- Complicated Ventral Abdominal Wall Hernia (Strangulated, Obstructed)
- Recurrent Hernias
- Renal Insufficiency: Serum Creatinine > 1.5
- Hepatic Insufficiency: Known case of chronic liver disease or Total Bilirubin > 2mg/dl
- Pregnant or lactating Females
- Emergency Operations
- Current or regular use of analgesics for some other indication
- Patients with known hypersensitivity to the study drug.
- Refusal to Informed Consent
- Simultaneous additional surgical procedures
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Abdominal Wall Defect
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Intervention(s)
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Other: Saline
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Drug: Bupivacaine
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Primary Outcome(s)
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Post-Operative Pain
[Time Frame: Scale will be presented to the participant at 24 hours post procedure.]
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Post-Operative Pain will be graded on visual analogue scale (VAS)
[Time Frame: Scale will be presented to the participant at 6 hours post procedure.]
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Secondary Outcome(s)
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Length of hospital stay
[Time Frame: Upto a maximum of 30 days from procedure]
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Secondary ID(s)
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HAPPIEST Trial
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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