Local Ketamine Instillation for Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642497
• Other study ID #: 342
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 24, 2015
• Last updated: January 1, 2017
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	possible side effects	occurrence of possible side effects during follow up	24 hours	Yes
Primary	total opioid consumption	the total amount of morphine consumed during follow up period	24 hours	No
Secondary	first request of analgesia	time to first request of rescue analgesic drug	24 hours	No
Secondary	VAS	effect of study drugs on postoperative pain measured by VAS score	24 hours	No