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

Assiut University

Status and phase: Completed; Phase 3

Conditions: Abdominal Cancer

Treatments: Drug: Bupivacaine; Drug: Dexmedetomidine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02927379

248

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

ketamine group

Active Comparator group

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.

Treatment:

Drug: Ketamine

dexmedetomidine group

Active Comparator group

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.

Treatment:

Drug: Dexmedetomidine

bupivacaine group

Placebo Comparator group

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).

Treatment:

Drug: Bupivacaine