Clinical trial · Interventional

Continuous Local-anesthetic Wound Infusion for Neck Dissection

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

NCT06201039CI-TRIAL-00072932CLAWEDunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
0.5% Lidocaine Hydrochloride	Drug	—	UNRESOLVED
0.9% Normal Saline	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
CWI Block
description
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.
interventionNames
1. Drug: 0.5% Lidocaine Hydrochloride
type
PLACEBO_COMPARATOR
label
CWI Placebo
description
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.
interventionNames
1. Drug: 0.9% Normal Saline

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 70 Years

Show eligibility criteria text

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.

References

Publications (15)

BACKGROUNDHinther 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
BACKGROUNDGostian 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
BACKGROUNDvan 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
BACKGROUNDWick 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
BACKGROUNDKehlet 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
BACKGROUNDMcLeod 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
BACKGROUNDTan 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.