NCT06201039

Continuous Local-anesthetic Wound Infusion for Neck Dissection

Continuous Local Anesthetic Wound Infusion to Improve Quality of Recovery Following Ablative Surgery and Neck Dissection: a Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to assess the efficacy of continuous local anesthetic wound infusion to improve quality of recovery following ablative surgery and neck dissection.

Detailed description

Bilateral cervical plexus catheters are convenient and safe to place under the direct vision of the surgeons during ablative and neck dissection. The investigators hypothesize that continuous local anesthetic wound infusion to block bilateral cervical plexus will improve quality of recovery following ablative surgery and neck dissection. The primary endpoint is the quality of recovery, which will be assessed using the 15-item quality of recovery questionnaire (QoR-15). Secondary endpoints include numeric pain scale, number and proportion of patients on salvage analgesics, Incidence of phrenic nerve block, Incidence of recurrent laryngeal nerve block, length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	0.5% Lidocaine Hydrochloride	Prior to the end of neck dissection and any additional procedures, the bilateral catheter will be placed adjacent to the cervical plexus underneath the internal jugular vein, left in place for 24 hours and removed in a similar way to the Redon drainage by the surgeon. The CWI block will start immediately at a speed of 4ml/h containing 0.5% lidocaine hydrochloride + 1:400000 adrenaline.
DRUG	0.9% Normal Saline	Prior to the end of neck dissection and any additional procedures, the bilateral catheter will be placed adjacent to the cervical plexus underneath the internal jugular vein, left in place for 72 hours and removed in a similar way to the Redon drainage by the surgeon. The CWI placebo will start immediately at a speed of 4ml/h containing 0.9% normal saline + 1:400000 adrenaline.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2024-01-11
• Last updated: 2024-01-11