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

January 10, 2024 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Continuous Local Anesthetic Wound Infusion to Improve Quality of Recovery Following Ablative Surgery and Neck Dissection: a Randomized Controlled Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 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
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.
Other Names:
  • CWI Block
Placebo Comparator: CWI Placebo

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 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.
Other Names:
  • CWI Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery
Time Frame: At 24 hours after surgery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
At 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative salvage analgesics
Time Frame: 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.
Up to 72 hours after surgery
Phrenic nerve block
Time Frame: Up to 72 hours after surgery
Patients will be asked to complete a daily diary for 72 hours that records their daily dyspnea.
Up to 72 hours after surgery
Numeric rating scale (NRS) for pain
Time Frame: 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).
Up to 72 hours after surgery
Recurrent laryngeal nerve block
Time Frame: Up to 72 hours after surgery
Patients will be asked to complete a daily diary for 72 hours that records their daily hoarseness.
Up to 72 hours after surgery
Quality of Recovery
Time Frame: Up to 72 hours after surgery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
Up to 72 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-anesthesia care unit (PACU) time
Time Frame: Intraoperative (At the end of surgery)
Length of PACU stay
Intraoperative (At the end of surgery)
Post-operative hospital time
Time Frame: Through study completion, an average of 1 year
Length of hospital stay
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Director: Ruan, The Sixth Affiliated hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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