Clinical trial NCT02012686: The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation for Reduction of Posterior Neck Pain After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Neck Pain
Keywords: transcutaneous electric nerve stimulation
thyroidectomy
neck pain
pain management
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after thyroidectomy.

Detailed description: Thyroidectomy is performed in supine position with the neck fully extended. After thyroidectomy, 80 percent of patients experience posterior neck pain as well as the incision site pain. The posterior neck pain is thought to be due to hyperextension is continued during an average of 90 minutes of surgery. Non-steroidal anti-inflammatory agents or opioids are administrated to reduce the pain, but the pain still remained.

TENS is simple, non-invasive analgesic technique that is used extensively to reduce acute and chronic pain. TENS has beneficial effect for the reduction of postoperative pain. The conventional way of administering TENS is to use electric characteristics that selectively activate large diameter Aβ fiber mediating touch perception without activating smaller diameter Aδ and C fiber.

In this study, TENS during thyroidectomy in posterior neck pain will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Undergoing open total thyroidectomy under general anesthesia
* American Society of Anesthesiology physical status I or II

Exclusion Criteria:

* American Society of Anesthesiology physical status III or IV
* History of headache or neck pain within six months
* Past history of herniated cervical disc, cervical foraminal stenosis, ossification of posterior longitudinal ligament

Primary outcomes:
measure: Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy
timeFrame: 0.5 hours after thyroidectomy
measure: Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy
timeFrame: 6 hours after thyroidectomy
measure: Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy
timeFrame: 24 hours after thyroidectomy
measure: Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy
timeFrame: 48 hours after thyroidectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea
name: Don Woo Han, M.D.,ph.D.
role: PRINCIPAL_INVESTIGATOR
References: