Continuous Local-anesthetic Wound Infusion for Neck Dissection
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: 0.5% Lidocaine HydrochlorideDrug: 0.9% Normal Saline
- Registration Number
- NCT06201039
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Over age 18;
- patients with head and neck cancer Undergoing ablative surgery and neck dissection.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CWI Block 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 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. CWI Placebo 0.9% Normal Saline 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.
- Primary Outcome Measures
Name Time Method Quality of Recovery At 24 hours after surgery The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
- Secondary Outcome Measures
Name Time Method Postoperative salvage analgesics Up to 72 hours after surgery Patients will be asked to complete a daily diary for 72 hours that records their daily postoperative salvage analgesics.
Phrenic nerve block Up to 72 hours after surgery Patients will be asked to complete a daily diary for 72 hours that records their daily dyspnea.
Numeric rating scale (NRS) for pain Up to 72 hours after surgery Patients will be asked to complete a daily diary for 72 hours that records the numeric pain rating scale composed of 0 (no pain at all) to 10 (worst imaginable pain).
Recurrent laryngeal nerve block Up to 72 hours after surgery Patients will be asked to complete a daily diary for 72 hours that records their daily hoarseness.
Quality of Recovery Up to 72 hours after surgery The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).