Intrathecal Ketamine, Dexmedetomidine and Both With Bupivacaine for Postoperative Abdominal Cancer Surgery Pain

NCT02455609 | Unknown Phase 2

• 1 other identifier: 210
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Currently, opioids are widely used for pain relief, but they often provide sub-optimal analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was introduced as a spinal anesthetic more than twenty years ago and found to have advantages over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in postoperative pain without severe sedation. The objectives of this study were to compare the efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their combination when added to bupivacaine for postoperative analgesia in major abdominal cancer surgery.

Conditions

Therapy; Pain Management

Keywords

dexmedetomidine; ketamine; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  efficacy of analgesia

  the first 24 hours postoperative

Secondary Outcomes (3)

• time to first request of analgesia

  the first 24 hours postoperative

• total analgesic consumption

  the first 24 hours postoperative

• side effects

  the first 24 hours postoperative

Study Arms (3)

dexmedetomidine (I)

ACTIVE COMPARATOR

intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume.

Procedure: intrathecal drug administration; Drug: Dexmedetomidine; Drug: Bupivacaine

ketamine (II)

ACTIVE COMPARATOR

intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume.

Procedure: intrathecal drug administration; Drug: ketamine; Drug: Bupivacaine

Dexmedetomidine + Ketamine group (III)

ACTIVE COMPARATOR

intrathecal drug administartion of patients in this arm received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume.

Procedure: intrathecal drug administration; Drug: Dexmedetomidine; Drug: ketamine; Drug: Bupivacaine

Interventions

intrathecal drug administration PROCEDURE

pre-emptive intrathecal administration of analgesic medications for control of postoperative pain.

Dexmedetomidine + Ketamine group (III); dexmedetomidine (I); ketamine (II)

Dexmedetomidine DRUG

Dexmedetomidine + Ketamine group (III); dexmedetomidine (I)

ketamine DRUG

Dexmedetomidine + Ketamine group (III); ketamine (II)

Bupivacaine DRUG

Dexmedetomidine + Ketamine group (III); dexmedetomidine (I); ketamine (II)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 30-50 years
• American Society of Anesthesia (ASA) I-II patients
• scheduled for major abdominal cancer surgery

You may not qualify if:

• known allergy to the study drugs.
• significant cardiac, respiratory, renal or hepatic disease
• coagulation disorder
• infection at the site of intrathecal injection
• drug or alcohol abuse
• BMI \> 30 kg/m2
• psychiatric illnesses that would interfere with perception and assessment of pain

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Dexmedetomidine; Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Ahmad M Abd El-Rahman, M.D.

  South Egypt Cancer Institute, Assiut University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, intensive care, and pain management

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 28, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05