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Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

Primary Purpose

Postoperative Analgesia, Lower Abdominal Cancer

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Ketamine

dexmedetomidine

control group

About this trial

This is an interventional treatment trial for Postoperative Analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study

Exclusion Criteria:

Coagulopathies
ASA III or IV, patient refusal, sensitivity to the used drugs

Sites / Locations

South Egypt Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group,

ketamine group,

dexmedetomidine group

Arm Description

saline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

ketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

dexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Outcomes

Primary Outcome Measures

postoperative rescue morphine consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT03060070

First Posted

February 17, 2017

Last Updated

July 1, 2017

Sponsor

Assiut University

Collaborators

South Egypt Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03060070

Brief Title

Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

Official Title

Comparison of the Analgesic Effect of Ketamine Versus Dexmedetomidine Added to Local Anesthetic in TAP Block for Lower Abdominal Cancer Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 10, 2017 (Actual)

Primary Completion Date

June 25, 2017 (Actual)

Study Completion Date

July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

Collaborators

South Egypt Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.

6. Conditions and Keywords

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

Postoperative Analgesia, Lower Abdominal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group,

Arm Type

Placebo Comparator

Arm Description

saline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Arm Title

ketamine group,

Arm Type

Active Comparator

Arm Description

ketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Arm Title

dexmedetomidine group

Arm Type

Active Comparator

Arm Description

dexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine

Intervention Description

dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block

Intervention Type

Drug

Intervention Name(s)

control group

Intervention Description

20ml of 0.25% bupivacaine will be injected in each side of the TAP block

Primary Outcome Measure Information:

Title

postoperative rescue morphine consumption

Description

postoperative rescue morphine consumption

Time Frame

24 hours postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study Exclusion Criteria: Coagulopathies ASA III or IV, patient refusal, sensitivity to the used drugs

Facility Information:

Facility Name

South Egypt Cancer Institute

City

Assiut

State/Province

Assiut University

ZIP/Postal Code

171516

Country

Egypt

12. IPD Sharing Statement

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Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

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