Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

NCT02577068 | Completed

• 1 other identifier: 4-2015-0746
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.

Conditions

Thyroidectomy; Pain

Outcome Measures

Primary Outcomes (1)

• VAS score on wound site and posterior neck

  Patients' subject pain score through VAS on the surgery wound site and posterior neck.

  one hour after the surgery

Secondary Outcomes (5)

• Additional pain rescue drug

  for postop. 24hrs.

• Postoperative nausea and vomiting

  for postop. 24hrs.

• Patient satisfaction

  for postop. 24hrs.

• Chronic pain and neurogenic pain

  three month after the surgery.

• acute VAS on wound site and posterior neck

  postop. 24hrs.

Study Arms (3)

nefopam group

ACTIVE COMPARATOR

Drug: Nefopam

propacetamol group

ACTIVE COMPARATOR

Drug: Propacetamol

nefopam and propacetamol group

EXPERIMENTAL

Drug: Nefopam; Drug: Propacetamol

Interventions

Nefopam DRUG

Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.

nefopam and propacetamol group; nefopam group

Propacetamol DRUG

Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.

nefopam and propacetamol group; propacetamol group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient who undergone open thyroidectomy
• \~70 years old
• ASA I\~III

You may not qualify if:

• hypersensitivity on Nefopam and Propacetamol
• Liver failure, chronic alcohol addiction
• severe hemolytic anemia, chronic nutrition deficiency
• history of seizure
• MI, MAO inhibitor
• pregnant, breast-feeding
• foreigners

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Han DW, Koo BN, Chung WY, Park CS, Kim SY, Palmer PP, Kim KJ. Preoperative greater occipital nerve block in total thyroidectomy patients can reduce postoperative occipital headache and posterior neck pain. Thyroid. 2006 Jun;16(6):599-603. doi: 10.1089/thy.2006.16.599.

  PMID: 16839262 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Nefopam; propacetamol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 16, 2015
• Study Start: November 15, 2015
• Primary Completion: August 23, 2016
• Study Completion: August 23, 2016
• Last Updated: March 21, 2019

Record last verified: 2019-02

Locations

KR (1)