A Phase 2/3 interventional study of Methylene blue group and Methylene blue group in Time Taken for Identification of Single Recurrent Laryngeal Nerve and Intra-operative Blood Loss, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
The aim of the study is to evaluate the value of injection of methylene blue dye into the inferior thyroid artery for the help of the identification and dissection of recurrent laryngeal nerve, so thyroidectomy could be done with fewer complications in comparison to conventional technique
The aim of the study is to evaluate the effectiveness of methylene blue dye injection into the inferior thyroid artery for enhancing the intraoperative visualization of the RLN during thyroidectomy. Also, this method was compared to conventional RLN identification techniques in terms of nerve identification time, blood loss, complication rates, and postoperative outcomes, while assessing the safety and feasibility of using methylene blue in thyroid surgery.
The study included 40 patients with indications for thyroidectomy due to benign thyroid conditions. Patients were randomly assigned into two equal groups:
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After ligation of the superior pole, 0.5-1 ml of sterile methylene blue dye was injected into the inferior thyroid artery. The thyroid tissue absorbed the dye, while the RLN remained unstained, appearing as a white structure in the tracheoesophageal groove. This aided in its early and safe identification, reducing the risk of injury during dissection.
Drug: Methylene blue group · Procedure: Methylene blue group
the RLN was identified based on conventional anatomical landmarks without the use of dye. The nerve was traced along its expected course near the inferior thyroid artery and ligament of Berry
After ligation of the superior pole, 0.5-1 ml of sterile methylene blue dye was injected into the inferior thyroid artery. The thyroid tissue absorbed the dye, while the RLN remained unstained, appearing as a white structure in the tracheoesophageal groove. This aided in its early and safe identification, reducing the risk of injury during dissection.
After ligation of the superior pole, 0.5-1 ml of sterile methylene blue dye was injected into the inferior thyroid artery. The thyroid tissue absorbed the dye, while the RLN remained unstained, appearing as a white structure in the tracheoesophageal groove. This aided in its early and safe identification, reducing the risk of injury during dissection.
Easy and fast identification of recurrent laryngeal nerve
Thyroid gland absorbed the dye and got stained blue while the RLN didn't take the dye and appeared as a white structure in the tracheoesophageal groove
Time frame: Procedure (Time taken for identification of the recurrent laryngeal nerve after delivery of thyroid lobe (in minutes))
Lower intra-operative blood loss
Intra-operative blood loss was significantly lower in the Methylene blue group in comparison to conventional technique
Time frame: The duration of the procedure ranging from one to two hours
Plan to share: Undecided — Undecided yet
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Ain Shams University