Local Ketamine Instillation for Postoperative Analgesia

NCT02642497 | Completed Phase 2

• 1 other identifier: 342
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.

Conditions

Postoperative Pain

Keywords

postoperative analgesia; ketamine; total thyroidectomy

Outcome Measures

Primary Outcomes (1)

• total opioid consumption

  the total amount of morphine consumed during follow up period

  24 hours

Secondary Outcomes (2)

• first request of analgesia

  24 hours

• VAS

  24 hours

Other Outcomes (1)

• possible side effects

  24 hours

Study Arms (3)

local ketamine group

ACTIVE COMPARATOR

intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

Drug: intra-wound instillation of ketamine

control group

PLACEBO COMPARATOR

intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

Drug: intra-wound instillation of normal saline

systemic ketamine group

ACTIVE COMPARATOR

Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.

Drug: systemic administration of ketamine

Interventions

intra-wound instillation of ketamine DRUG

intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure

local ketamine group

intra-wound instillation of normal saline DRUG

intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure

Also known as: placebo

control group

systemic administration of ketamine DRUG

intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.

systemic ketamine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with thyroid cancer scheduled for total thyroidectomy.

You may not qualify if:

• BMI\>35
• Unstable ischaemic cardiac disease
• Increased intracranial pressure
• Increased intraocular pressure
• Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
• Severe psychiatric disease
• Unwillingness or inability to use PCA-device
• Inability to use VAS scale

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 30, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2017-01