Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress
Brief Summary
Intervention / Treatment
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Dexmedetomidine (DRUG)local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus dexmetedomidine in two divided doses i.e. 20 ml is administered on each side of incision
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Ketamine (DRUG)local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus ketamine in two divided doses i.e. 20 ml is administered on each side of incision
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Bupivacaine (DRUG)local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline only in two divided doses i.e. 20 ml is administered on each side of incision
Condition or Disease
- Abdominal Cancer
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 60 Years |
| Enrollment: | 90 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Health Services Research |
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Clinical Trial Dates
| Start date: | Jun 01, 2016 | |
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| Primary Completion: | Dec 01, 2016 | ACTUAL |
| Completion Date: | Oct 01, 2017 | ACTUAL |
| Study First Posted: | Oct 07, 2016 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 08, 2018 |
Sponsors / Collaborators
Location
Group C:
30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).
Group K:
30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
Group D:
30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
Participant Groups
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intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
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intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
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intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 60 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
* American Society of Anesthesiologists (ASA) class I-II Body weight of 50 - 90 kg
Exclusion Criteria:
* History of bleeding diathesis
* Relevant drug allergy, opioid dependence
* Morbid obesity, sepsis
Primary Outcomes
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Total morphine consumption 24 hours
Secondary Outcomes
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Plasma concentrations of prolactin, cortisol and glucose level 24 hours
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the severity of pain was assessed using VAS score 24 hours
More Details
| NCT Number: | NCT02927379 |
|---|---|
| Other IDs: | 248 |
| Study URL: | https://clinicaltrials.gov/study/NCT02927379 |