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Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress

Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress Response and Postoperative Pain in Major Abdominal Cancer Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02927379
Enrollment
90
Registered
2016-10-07
Start date
2016-06-30
Completion date
2017-10-31
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Cancer

Brief summary

This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower abdominal cancer surgery.

Detailed description

Patients will be randomly assigned using an online research randomizer into three groups, 30 patients in each group: 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.

Interventions

DRUGDexmedetomidine

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

DRUGKetamine

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

DRUGBupivacaine

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Total morphine consumption24 hours

Secondary

MeasureTime frame
Plasma concentrations of prolactin, cortisol and glucose level24 hours
the severity of pain was assessed using VAS score24 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026