Local Ketamine Instillation for Postoperative Analgesia

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: intra-wound instillation of ketamine; Drug: intra-wound instillation of normal saline; Drug: systemic administration of ketamine

• Registration Number: NCT02642497
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Primary Completion: 2016-02
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-01
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

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

Inclusion Criteria

• patients with thyroid cancer scheduled for total thyroidectomy.

Exclusion Criteria

1. BMI>35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
6. Severe psychiatric disease
7. Unwillingness or inability to use PCA-device
8. Inability to use VAS scale

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
local ketamine group	intra-wound instillation of ketamine	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.
control group	intra-wound instillation of normal saline	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.
systemic ketamine group	systemic administration of ketamine	Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.

Primary Outcome Measures

Name	Time	Method
total opioid consumption	24 hours	the total amount of morphine consumed during follow up period

Secondary Outcome Measures

Name	Time	Method
first request of analgesia	24 hours	time to first request of rescue analgesic drug
VAS	24 hours	effect of study drugs on postoperative pain measured by VAS score