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

Primary Purpose

Abdominal Cancer

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
Bupivacaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Abdominal Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Egypt Cancer Instuite

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ketamine group

dexmedetomidine group

bupivacaine group

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

Total morphine consumption

Secondary Outcome Measures

Plasma concentrations of prolactin, cortisol and glucose level
the severity of pain was assessed using VAS score

Full Information

First Posted
October 5, 2016
Last Updated
January 8, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02927379
Brief Title
Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress
Official Title
Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress Response and Postoperative Pain in Major Abdominal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketamine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bupivacaine group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
subcutaneous
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
subcutaneous
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
subcutaneous
Intervention Description
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
Primary Outcome Measure Information:
Title
Total morphine consumption
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Plasma concentrations of prolactin, cortisol and glucose level
Time Frame
24 hours
Title
the severity of pain was assessed using VAS score
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatma A EL sherif
Organizational Affiliation
South Egypt Cancer Instuite, Assuit, Assuit university
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Instuite
City
Assuit
ZIP/Postal Code
171516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29388288
Citation
Mohamed SA, Sayed DM, El Sherif FA, Abd El-Rahman AM. Effect of local wound infiltration with ketamine versus dexmedetomidine on postoperative pain and stress after abdominal hysterectomy, a randomized trial. Eur J Pain. 2018 May;22(5):951-960. doi: 10.1002/ejp.1181. Epub 2018 Feb 1.
Results Reference
derived

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

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