Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

Study Overview
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Brief Summary
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Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV)

Detailed Description
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Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients describe PONV as more irritant in the postoperative course than the endured pain. Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and parathyroid surgery in a randomized controlled clinical trial.

Official Title
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Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Device: Placement of a wound drain post surgery (Redon; Medicoplast)
* Other: No-drain after surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older than 18 years of age informed consent planed thyroid- or parathyroid resection euthyreostatic preoperative condition Exclusion Criteria: younger than 18 years of age pregnancy no informed consent retrosternal struma known postoperative nausea and vomiting prior to surgery severe and life threatening systemic health issues

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drain placement (Group A)<br>Patients in group A received a wound drain after surgery. | Device: Placement of a wound drain post surgery (Redon; Medicoplast)<br>* The wound drain, type Redon Drainage 3.0 mm in diameter<br>* Other names: Medicoplast, 66557 Illingen, Germany;|
| Sham Comparator: No-drain placement (group B)<br>Patients assigned to group B, did not receive a wound drain after surgery. | Other: No-drain after surgery<br>* After surgery, no drain was put<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of post-operative nausea using visual analogue scale (VAS) | The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10. | 24 hours post surgery | 
| Assessment of postoperative vomiting using visual analogue scale (VAS) | The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery | 24 hours post surgery | 
| Assessment of post-operative nausea using visual analogue scale (VAS) | The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10. | 48 hours post surgery | 
| Assessment of postoperative vomiting using visual analogue scale (VAS) | The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery | 48 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiemetic therapy post surgery in patients with and without postoperative drainage | In the postoperative course, we counted the amount of anti-emetic interventions for patients post surgery over the first 48 hours. The givage of anti-emetic drugs was based on a prior determined protocol, that was strictly followed. The protocol was as follows for antiemetic drugs: First line Drug: Tropisetron 2 mg i.v. when patient is vomiting, max. twice a day. Second line therapy: Haloperidol 0.5 mg i.v. with a maximum of 3 mg every 24 hours, when first line therapy is not sufficient. The change to second line therapy is controlled by the study physician. | after 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, postoperative, PONV, thyroid, surgery