Local Ketamine Instillation for Postoperative Analgesia

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02642497

Enrollment

Registered

2015-12-30

Start date

2015-08-31

Completion date

2016-12-31

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

postoperative analgesia, ketamine, total thyroidectomy

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.

Interventions

DRUGintra-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

DRUGintra-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

DRUGsystemic administration of ketamine

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
total opioid consumption	24 hours	the total amount of morphine consumed during follow up period

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
possible side effects	24 hours	occurrence of possible side effects during follow up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026