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

Phase 3

Completed

• Conditions: Abdominal Cancer
• Interventions: Drug: Ketamine; Drug: Dexmedetomidine; Drug: Bupivacaine

• Registration Number: NCT02927379
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-07
• Primary Completion: 2016-12
• Status Verified: 2017-06
• Study Completion: 2017-10
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine group	Ketamine	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.
dexmedetomidine group	Dexmedetomidine	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.
bupivacaine group	Bupivacaine	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).

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of prolactin, cortisol and glucose level	24 hours
the severity of pain was assessed using VAS score	24 hours

Trial Locations

Locations (1)

South Egypt Cancer Instuite; 🇪🇬 Assuit, Egypt