An interventional study of 0.5% Lidocaine Hydrochloride and 0.9% Normal Saline in Head and Neck Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Not yet recruiting. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's planned enrollment of 80 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
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.
Drug: 0.5% Lidocaine Hydrochloride
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.
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 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.
Also known as: CWI Block
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.
Also known as: CWI Placebo
Quality of Recovery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
Time frame: At 24 hours after surgery
Postoperative salvage analgesics
Patients will be asked to complete a daily diary for 72 hours that records their daily postoperative salvage analgesics.
Time frame: Up to 72 hours after surgery
Phrenic nerve block
Patients will be asked to complete a daily diary for 72 hours that records their daily dyspnea.
Time frame: Up to 72 hours after surgery
Numeric rating scale (NRS) for pain
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).
Time frame: Up to 72 hours after surgery
Recurrent laryngeal nerve block
Patients will be asked to complete a daily diary for 72 hours that records their daily hoarseness.
Time frame: Up to 72 hours after surgery
Quality of Recovery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
Time frame: Up to 72 hours after surgery
Post-anesthesia care unit (PACU) time
Length of PACU stay
Time frame: Intraoperative (At the end of surgery)
Post-operative hospital time
Length of hospital stay
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: No
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Sixth Affiliated Hospital, Sun Yat-sen University