Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery | The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15). | At 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative salvage analgesics | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-anesthesia care unit (PACU) time | Length of PACU stay | Intraoperative (At the end of surgery) |
| Post-operative hospital time | Length of hospital stay |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen | Contact | +8613922106109 | 153856346@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruan | The Sixth Affiliated Hospital, Sun Yat-sen University | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33809273 | Background | 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. | |
| 33830180 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants, clinicians, data collectors, outcome adjudicators and data analysts will not have access to details of group assignment.
|
|
| 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. |
|
|
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 | 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 | 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 | The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15). | Up to 72 hours after surgery |
| Through study completion, an average of 1 year |
| 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. |
| 17355955 | 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. |
| 28564673 | 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. |
| 9175983 | 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. |
| 25692358 | 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. |
| 25501696 | 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. |
| 26835644 | 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. |
| 29016552 | 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. |
| 27737447 | 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. |
| 15113770 | 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. |
| 32517389 | 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. |
| 34388135 | 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. |
| 27380104 | 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. |
| 26518201 | 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. |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |