Local Ketamine Instillation for Postoperative Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Postoperative Analgesia Offered by Local Ketamine Wound Instillation Following Total Thyroidctomy; a Randomized, Double-blind, Controlled-clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: intra-wound instillation of ketamine
* Drug: intra-wound instillation of normal saline
* Drug: systemic administration of ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with thyroid cancer scheduled for total thyroidectomy. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: local ketamine group<br>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<br>* 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<br>|
| Placebo Comparator: control group<br>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<br>* 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<br>* Other names: placebo;|
| Active Comparator: systemic ketamine group<br>Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure. | Drug: systemic administration of ketamine<br>* intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid consumption | the total amount of morphine consumed during follow up period | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first request of analgesia | time to first request of rescue analgesic drug | 24 hours | 
| VAS | effect of study drugs on postoperative pain measured by VAS score | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgesia, ketamine, total thyroidectomy