Head and Neck Cancer
Conditions
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.
Interventions
DRUG0.5% 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.
DRUG0.9% 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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, clinicians, data collectors, outcome adjudicators and data analysts will not have access to details of group assignment.
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | At 24 hours after surgery | The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-anesthesia care unit (PACU) time | Intraoperative (At the end of surgery) | Length of PACU stay |
| Post-operative hospital time | Through study completion, an average of 1 year | Length of hospital stay |
Contacts
Primary ContactChen
Outcome results
None listed