Clinical trial NCT06201039: Continuous Local-anesthetic Wound Infusion for Neck Dissection
Official title: Continuous Local Anesthetic Wound Infusion to Improve Quality of Recovery Following Ablative Surgery and Neck Dissection: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Recovery
timeFrame: At 24 hours after surgery
Secondary outcomes:
measure: Postoperative salvage analgesics
timeFrame: Up to 72 hours after surgery
measure: Phrenic nerve block
timeFrame: Up to 72 hours after surgery
measure: Numeric rating scale (NRS) for pain
timeFrame: Up to 72 hours after surgery
measure: Recurrent laryngeal nerve block
timeFrame: Up to 72 hours after surgery
measure: Quality of Recovery
timeFrame: Up to 72 hours after surgery
Other outcomes:
measure: Post-anesthesia care unit (PACU) time
timeFrame: Intraoperative (At the end of surgery)
measure: Post-operative hospital time
timeFrame: Through study completion, an average of 1 year
Locations:
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Ruan
role: STUDY_DIRECTOR
References:
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