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

NCT ID: NCT02927379

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Abdominal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ketamine group

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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type 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

dexmedetomidine group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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

bupivacaine group

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).

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type 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

Interventions

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Dexmedetomidine

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

Ketamine

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

Bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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subcutaneous subcutaneous subcutaneous

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatma A EL sherif

Role: PRINCIPAL_INVESTIGATOR

South Egypt Cancer Instuite, Assuit, Assuit university

Locations

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South Egypt Cancer Instuite

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 29388288 (View on PubMed)

Other Identifiers

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248

Identifier Type: -

Identifier Source: org_study_id

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