Continuous Local-anesthetic Wound Infusion for Neck Dissection

NCT06201039 | Unknown

• 1 other identifier: 2022-091
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).

  At 24 hours after surgery

Secondary Outcomes (5)

• Postoperative salvage analgesics

  Up to 72 hours after surgery

• Phrenic nerve block

  Up to 72 hours after surgery

• Numeric rating scale (NRS) for pain

  Up to 72 hours after surgery

• Recurrent laryngeal nerve block

  Up to 72 hours after surgery

• Quality of Recovery

  Up to 72 hours after surgery

Other Outcomes (2)

• Post-anesthesia care unit (PACU) time

  Intraoperative (At the end of surgery)

• Post-operative hospital time

  Through study completion, an average of 1 year

Study Arms (2)

CWI Block

EXPERIMENTAL

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

CWI Placebo

PLACEBO COMPARATOR

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

Interventions

0.5% Lidocaine Hydrochloride DRUG

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

CWI Block

0.9% Normal Saline DRUG

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

CWI Placebo

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Over age 18;
• patients with head and neck cancer Undergoing ablative surgery and neck dissection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Related Publications (15)

• Hinther A, Nakoneshny SC, Chandarana SP, Matthews TW, Hart R, Schrag C, Matthews J, McKenzie CD, Fick GH, Dort JC. Efficacy of Multimodal Analgesia for Postoperative Pain Management in Head and Neck Cancer Patients. Cancers (Basel). 2021 Mar 12;13(6):1266. doi: 10.3390/cancers13061266.

  PMID: 33809273 BACKGROUND

• Gostian M, Loeser J, Albert C, Wolber P, Schwarz D, Grosheva M, Veith S, Goerg C, Balk M, Gostian AO. Postoperative Pain Treatment With Continuous Local Anesthetic Wound Infusion in Patients With Head and Neck Cancer: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Jun 1;147(6):553-560. doi: 10.1001/jamaoto.2021.0327.

  PMID: 33830180 BACKGROUND

• van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.

  PMID: 17355955 BACKGROUND

• Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.

  PMID: 28564673 BACKGROUND

• Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

  PMID: 9175983 BACKGROUND

• McLeod RS, Aarts MA, Chung F, Eskicioglu C, Forbes SS, Conn LG, McCluskey S, McKenzie M, Morningstar B, Nadler A, Okrainec A, Pearsall EA, Sawyer J, Siddique N, Wood T. Development of an Enhanced Recovery After Surgery Guideline and Implementation Strategy Based on the Knowledge-to-action Cycle. Ann Surg. 2015 Dec;262(6):1016-25. doi: 10.1097/SLA.0000000000001067.

  PMID: 25692358 BACKGROUND

• Tan M, Law LS, Gan TJ. Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways. Can J Anaesth. 2015 Feb;62(2):203-18. doi: 10.1007/s12630-014-0275-x. Epub 2014 Dec 10.

  PMID: 25501696 BACKGROUND

• Ladha KS, Patorno E, Huybrechts KF, Liu J, Rathmell JP, Bateman BT. Variations in the Use of Perioperative Multimodal Analgesic Therapy. Anesthesiology. 2016 Apr;124(4):837-45. doi: 10.1097/ALN.0000000000001034.

  PMID: 26835644 BACKGROUND

• Schwenk ES, Grant AE, Torjman MC, McNulty SE, Baratta JL, Viscusi ER. The Efficacy of Peripheral Opioid Antagonists in Opioid-Induced Constipation and Postoperative Ileus: A Systematic Review of the Literature. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):767-777. doi: 10.1097/AAP.0000000000000671.

  PMID: 29016552 BACKGROUND

• Dort JC, Farwell DG, Findlay M, Huber GF, Kerr P, Shea-Budgell MA, Simon C, Uppington J, Zygun D, Ljungqvist O, Harris J. Optimal Perioperative Care in Major Head and Neck Cancer Surgery With Free Flap Reconstruction: A Consensus Review and Recommendations From the Enhanced Recovery After Surgery Society. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):292-303. doi: 10.1001/jamaoto.2016.2981.

  PMID: 27737447 BACKGROUND

• Telford RJ, Stoneham MD. Correct nomenclature of superficial cervical plexus blocks. Br J Anaesth. 2004 May;92(5):775; author reply 775-6. doi: 10.1093/bja/aeh550. No abstract available.

  PMID: 15113770 BACKGROUND

• Petrucci E, Cofini V, Pizzi B, Coletta R, Blasetti AG, Necozione S, Fusco P, Marinangeli F. Intermediate Cervical Plexus Block in the Management of Persistent Postoperative Pain Post Carotid Endarterectomy: A Prospective, Randomized, Controlled, Clinical Trial. Pain Physician. 2020 Jun;23(3):237-244.

  PMID: 32517389 BACKGROUND

• Bhoi D, Bhatia R, Mohan VK, Thakar A, Kalagara R, Sikka K. Efficacy of Ultrasound-Guided Intermediate Cervical Plexus Block by Anterior Route for Perioperative Analgesia in Robotic Thyroidectomy by Retroauricular Approach: A Case Series. A A Pract. 2021 Aug 12;15(8):e01501. doi: 10.1213/XAA.0000000000001501.

  PMID: 34388135 BACKGROUND

• Kim JS, Lee J, Soh EY, Ahn H, Oh SE, Lee JD, Joe HB. Analgesic Effects of Ultrasound-Guided Serratus-Intercostal Plane Block and Ultrasound-Guided Intermediate Cervical Plexus Block After Single-Incision Transaxillary Robotic Thyroidectomy: A Prospective, Randomized, Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):584-8. doi: 10.1097/AAP.0000000000000430.

  PMID: 27380104 BACKGROUND

• Bu XS, Zhang J, Zuo YX. Validation of the Chinese Version of the Quality of Recovery-15 Score and Its Comparison with the Post-Operative Quality Recovery Scale. Patient. 2016 Jun;9(3):251-9. doi: 10.1007/s40271-015-0148-6.

  PMID: 26518201 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ruan

  The Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Chen

CONTACT

+8613922106109; 153856346@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinicians, data collectors, outcome adjudicators and data analysts will not have access to details of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: January 11, 2024
• Study Start: March 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share