Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes

Post-operative Pain Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620151
• Other study ID #: RCTECS001
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: December 18, 2013
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Primary: To compare the post-operative pain in patients with neck extension and without neck extension.

Secondary: To determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups.

Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less post-operative pain and there are no significant difference of post-operation complications between both groups.

Description:

Conventional open thyroid surgery is still one of the most common operations performed globally. Traditionally, patients who undergoing thyroid surgeries are usually positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier. However, the degree of benefit from the extended neck is doubtful and there is little objective evidence that suggest extended neck thyroid surgery offers better outcomes. On the the hand, over-extension of the neck should be avoided because of it is associated with post-operative pain, vomiting, spinal damage and stroke. The objective of the present study is to compare the post-operative pain in patients with neck extension and without neck extension. In addition to that, we also like to determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups. This is a prospective randomized controlled trial, which will be conducted from 1st of March 2012 till 30th September 2012. Given that approximately 300 to 400 patients would undergo thyroid surgery in each year, we estimated 180 patients will be recruited and randomly divided into 2 groups (neck extension and no neck extension) before undergoing open thyroid surgery for this trial. Visual analogue scale (VAS) is used to determine the post-operative pain. Primary end point and other peri-operative variables are then analyzed with SPSS software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients who will be undergoing thyroid surgery in Queen Mary Hospital and Tung Wah Hospital.

• Age from 18 till 80 years old.

Exclusion Criteria:

• Patients with history of bleeding disorder and tendency.

• Patients with history of cervical spine surgery and disease.

• Patients with history of RLN injury and underlying cause of hypocalcemia.

• Patient with mental disorder and subnormal intelligence.

• Pregnant and lactating women.

• Patients who is having other surgical problem that needed other surgical procedure performed at the same setting.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• Extended neck with standard support or pillow
Patient will undergo thyroid surgery with an extended neck

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tung Wah Hospital	Sheung Wan

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (9)

Bae JS, Park WC, Song BJ, Jung SS, Kim JS. Endoscopic thyroidectomy and sentinel lymph node biopsy via an anterior chest approach for papillary thyroid cancer. Surg Today. 2009;39(2):178-81. doi: 10.1007/s00595-008-3840-5. Epub 2009 Feb 7. — View Citation

Beaver WT. Management of cancer pain with parenteral medication. JAMA. 1980 Dec 12;244(23):2653-7. — View Citation

Clements RH, Palepu R. In vivo comparison of the coagulation capability of SonoSurg and Harmonic Ace on 4 mm and 5 mm arteries. Surg Endosc. 2007 Dec;21(12):2203-6. Epub 2007 May 4. — View Citation

Lang BH, Lo CY. Total thyroidectomy for multinodular goiter in the elderly. Am J Surg. 2005 Sep;190(3):418-23. — View Citation

Park CS, Chung WY, Chang HS. Minimally invasive open thyroidectomy. Surg Today. 2001;31(8):665-9. — View Citation

Serpell JW, Grodski SF, O'Donell C. Does neck extension elevate the thyroid gland cephalad to potentially improve access during thyroidectomy? ANZ J Surg. 2003 Nov;73(11):887-9. — View Citation

Terris DJ, Bonnett A, Gourin CG, Chin E. Minimally invasive thyroidectomy using the Sofferman technique. Laryngoscope. 2005 Jun;115(6):1104-8. — View Citation

Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. — View Citation

Weintraub MI, Khoury A. Cerebral hemodynamic changes induced by simulated tracheal intubation: a possible role in perioperative stroke? Magnetic resonance angiography and flow analysis in 160 cases. Stroke. 1998 Aug;29(8):1644-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain score	Post-operative pain ranges from 0 to 10 according to the Visual Analogue pain scale (VAS), and which 0 is 'No pain' and 10 is 'Worst possible pain'	First postoperative week	No
Secondary	Surgically related complications	Neck exposure, duration of operation, skin incision length, intra-operative blood loss, RLN injury, post-operative hypocalcaemia	Immediate and after 6 months	No
Secondary	Postoperative pain scores	Post-operative pain ranges from 0 to 10 according to the Visual Analogue pain scale (VAS), and which 0 is 'No pain' and 10 is 'Worst possible pain'	Day 0, day 1 and after two weeks	No