Continuous Local-anesthetic Wound Infusion for Neck Dissection (CLAWED)

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Head and Neck Cancer

Treatments: Drug: 0.9% Normal Saline; Drug: 0.5% Lidocaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06201039

2022-091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over age 18;
• patients with head and neck cancer Undergoing ablative surgery and neck dissection.

Exclusion criteria

• Patient refuse;
• Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history;
• Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment;
• Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months;
• Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

CWI Block

Experimental group

Description:

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 Continuous placebo Wound Infusion (CWI) will start immediately at a speed of 4ml/h containing 0.5% lidocaine hydrochloride + 1:400000 adrenaline. • Intervention: Drug: 0.5% lidocaine hydrochloride at 4ml/h.

Treatment:

Drug: 0.5% Lidocaine Hydrochloride

CWI Placebo

Placebo Comparator group

Description:

Control Intervention: Patients in the control arm will undergo the CWI procedure as well. The infusion will contain 0.9% normal saline + 1:400000 adrenaline at 4ml/h. • Intervention: Drug: 0.9% normal saline at 4ml/h.

Treatment:

Drug: 0.9% Normal Saline