Local Ketamine Instillation for Postoperative Analgesia

January 1, 2017 updated by: Ahmad Mohammad Abd El-Rahman, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total opioid consumption
Time Frame: 24 hours
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 Frame: 24 hours
time to first request of rescue analgesic drug
24 hours
VAS
Time Frame: 24 hours
effect of study drugs on postoperative pain measured by VAS score
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
possible side effects
Time Frame: 24 hours
occurrence of possible side effects during follow up
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 24, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 1, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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