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Completed

NCT Number: NCT02642497

Local Ketamine Instillation for Postoperative Analgesia

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other names: placebo

systemic administration of ketamine

Drug

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

Primary outcomes

  1. total opioid consumption

    Time frame: 24 hours

    the total amount of morphine consumed during follow up period

Secondary outcomes

  1. first request of analgesia

    Time frame: 24 hours

    time to first request of rescue analgesic drug

  2. VAS

    Time frame: 24 hours

    effect of study drugs on postoperative pain measured by VAS score

Other outcomes

  1. possible side effects

    Time frame: 24 hours

    occurrence of possible side effects during follow up

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2015
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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