Head and Neck CancerCLAWEDNCT06201039
Continuous Local-anesthetic Wound Infusion for Neck Dissection
A study testing 0.5% Lidocaine Hydrochloride and 0.9% Normal Saline in people with Head and Neck Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 0.5% Lidocaine Hydrochloride and 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Over age 18;
- patients with head and neck cancer Undergoing ablative surgery and neck dissection.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- 0.5% Lidocaine Hydrochloride, 0.9% Normal Saline
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Lidocaine HydrochlorideDrug
Also called 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 CWI block will start immediately at a speed of 4ml/h containing 0.5% lidocaine hydrochloride + 1:400000 adrenaline.
0.9% Normal SalineDrug
Also called CWI Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
Measured: At 24 hours after surgery
Secondary outcomes (5)
Postoperative salvage analgesics
Patients will be asked to complete a daily diary for 72 hours that records their daily postoperative salvage analgesics.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 72 hours after surgery
Quality of Recovery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
Measured: Up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruan, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201039
- Sponsor's protocol ID
- 2022-091
- Acronym
- CLAWED
- Status last verified
- Jan 2024
- First submitted
- 3 Apr 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33809273Gostian 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.
PubMed 33830180van 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.
PubMed 17355955Wick 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.
PubMed 28564673Kehlet 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.
PubMed 9175983McLeod 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.
PubMed 25692358Tan 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.
PubMed 25501696Ladha 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.
PubMed 26835644Schwenk 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.
PubMed 29016552Dort 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.
PubMed 27737447Telford 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.
PubMed 15113770Petrucci 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.
PubMed 32517389Bhoi 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.
PubMed 34388135Kim 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.
PubMed 27380104Bu 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.
PubMed 26518201
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Local Anesthetic Wound Infusion to Improve Quality of Recovery Following Ablative Surgery and Neck Dissection: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06201039
- Acronym / sponsor ID
- CLAWED / 2022-091
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CWI Block | Experimental | Drug: 0.5% Lidocaine HydrochloridePrior 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. |
| CWI Placebo | Placebo comparator | Drug: 0.9% Normal SalineControl 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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Over age 18;
- patients with head and neck cancer Undergoing ablative surgery and neck dissection.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% Lidocaine HydrochlorideAlso: CWI BlockPrior 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. | Drug | CWI Block |
| 0.9% Normal SalineAlso: CWI PlaceboPrior 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. | Drug | CWI Placebo |
Primary outcome
Quality of Recovery
Time frame: At 24 hours after surgery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
5 secondary outcomes
Postoperative salvage analgesics
Time frame: Up to 72 hours after surgery
Phrenic nerve block
Time frame: Up to 72 hours after surgery
Numeric rating scale (NRS) for pain
Time frame: Up to 72 hours after surgery
Recurrent laryngeal nerve block
Time frame: Up to 72 hours after surgery
Quality of Recovery
Time frame: Up to 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 33809273Hinther 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.
- Background: PubMed 33830180Gostian 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.
- Background: PubMed 17355955van 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.
- Background: PubMed 28564673Wick 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.
- Background: PubMed 9175983Kehlet 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.
- Background: PubMed 25692358McLeod 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.
- Background: PubMed 25501696Tan 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.
- Background: PubMed 26835644Ladha 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.
- Background: PubMed 29016552Schwenk 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.
- Background: PubMed 27737447Dort 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.
- Background: PubMed 15113770Telford 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.
- Background: PubMed 32517389Petrucci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruan study director
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing 0.5% Lidocaine Hydrochloride and 0.9% Normal Saline in people with Head and Neck Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen (+8613922106109, 153856346@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: At 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201039, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.