Clinical trial · Interventional

ESP Versus TEA for Oeasophagus Cancer Surgery

Bilateral Asymmetrical Erector Spinae Catheters Analgesia Versus Thoracic Epidural Catheter Analgesia in Minimally Invasive Oesophageal Cancer Surgery: a Randomized Controlled Trial

NCT05631834CI-TRIAL-00068855ESPOKunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

For esophagectomy, peri-operative continuous thoracic epidural analgesia (TEA) is the standard of care for perioperative pain management. Although effective, TEA is associated with moderate to serious adverse events such as hypotension and neurologic complications. Peri-operative continuous Erector spinae analgesia (ESP) may be a safe alternative. The Investigators hypothesize that TEA and ESP are similar in efficacy for pain treatment in thoracolaparoscopic esophagectomy with less side effects. Methods. This Randomized prospective randomized study will compare TEA (Which is a wellknown technique of regional anaesthesia with numerous publications) with ESP ( Which is a technique of regional anaesthesia described in 2016 and with already 1000 publication) in a consecutive series of 50 thoracolaparoscopic esophagectomies randomized in 2 groups study groups ESP and controled group TEA. In this study, * The TEA will consist of continuous epidural ropivacaine and sufen- tanil infusion with an induction dose for the surgery and a programmed intermittent bolus (PIB) started at the end of the surgery and ended 72h after the end of the surgery. * The ESP; the Bilateral catheters will be inserted under ultrasound guidance after the anaesthesia induction with an induction dose and a PIB started at the end of the surgery and ended 72h after the end of the surgery. The primary outcome will be the median highest recorded Visual Analogic Scale (VAS) during the 3 days after surgery. The secondary outcomes will be vaso-pressor consumption, fluid administration, and length of hospital stay.

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
Peri Operative Analgesia	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Erector spinae block	Procedure	—	UNRESOLVED
Thoracic epidurale	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Continuous Peri operative Thoracic epidural catheters analgesia
description
Epidural catheter insertion will be performed at level T9 with catheter tip at level T7 After negative test dose with Lidocaine 2%, loading dose using Ropivacaine 0.5% (see table). Patient height (cm) Volume of LA (mL) 140-149 8 150-159 10 160-169 12 170-180 14 \>180 16 Evaluation of sensory block should be at level T4 to T10 by cold test and pinprick. If extension needed, bolus of ropivacaine 0.5% 2 mL may be added. In post operative period▪ analgesia with intermitent automatic bolus UAB of ropivacaine 0.2% will be connected and started at 10 min after arrival in post operative care unit ▪ Pump preparation and settings: Patient 140 - 149 cm = 8 mL Patient 150 - 159 cm = 10 mL Patient 160 - 169 cm = 12 mL Patient 170 - 180 cm = 14 mL Patient \>180 cm = 16 mL IAB every 4h reduced to 3h if needed Catheter will be removed 72h after end of surgery
interventionNames
1. Procedure: Thoracic epidurale
type
EXPERIMENTAL
label
Continuous Peri operative Bilateral erector spinae catheters analgesia
description
The ESP will be performed Right side level The tip of the catheter should be on t T7. Left side level The tip of the catheter should be on T8. Induction with ropivacaine 0.5% with loading dose as follows: Patient height (cm) Volume of LA (mL) LEFT RIGHT 140-149 8 6 150-159 10 8 160-169 12 10 170-180 14 12 \>180 16 14 For post operative analgesia: * Pumps with intermittent automatic bolus (IAB) of ropivacaine 0.2% started at 10 min after arrival in PACU * Patient 140 - 149 cm = 6 mL / left side - 8 mL / right side * Patient 150 - 159 cm = 8 mL / left side - 10 mL / right side * Patient 160 - 169 cm = 10 mL / left side - 12 mL / right side * Patient 170 - 179 = 12 mL / left side - 14 mL / right side * Patient \> 180 kg = 14 mL / side - 16 mL / right side The bolus on the second catheter will be delayed by 1 hour IAB every 6h Catheter will be removed 72h after end of surgery

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients who are diagnosed with esophageal cancer and scheduled to for TLE using Akiyama technique,
* Informed and signed the consent

Exclusion Criteria:

* patient refusal,
* allergy to local anesthetic (LA),
* complex congenital malformation,
* mental deficit,
* substance abuse (alcohol, opioids, etc.)
* renal insufficiency

References

Publications (30)

RESULTChan KKW, Saluja R, Delos Santos K, Lien K, Shah K, Cramarossa G, Zhu X, Wong RKS. Neoadjuvant treatments for locally advanced, resectable esophageal cancer: A network meta-analysis. Int J Cancer. 2018 Jul 15;143(2):430-437. doi: 10.1002/ijc.31312. Epub 2018 Mar 8. PMID 29441562
RESULTGisbertz SS, Hagens ERC, Ruurda JP, Schneider PM, Tan LJ, Domrachev SA, Hoeppner J, van Berge Henegouwen MI. The evolution of surgical approach for esophageal cancer. Ann N Y Acad Sci. 2018 Dec;1434(1):149-155. doi: 10.1111/nyas.13957. Epub 2018 Sep 7. PMID 30191569
RESULTSimonnet G, Rivat C. Opioid-induced hyperalgesia: abnormal or normal pain? Neuroreport. 2003 Jan 20;14(1):1-7. doi: 10.1097/00001756-200301200-00001. No abstract available. PMID 12544821
RESULTRichebe P, Cahana A, Rivat C. Tolerance and opioid-induced hyperalgesia. Is a divorce imminent? Pain. 2012 Aug;153(8):1547-1548. doi: 10.1016/j.pain.2012.05.002. Epub 2012 May 17. No abstract available. PMID 22608577
RESULTRivat C, Bollag L, Richebe P. Mechanisms of regional anaesthesia protection against hyperalgesia and pain chronicization. Curr Opin Anaesthesiol. 2013 Oct;26(5):621-5. doi: 10.1097/01.aco.0000432511.08070.de. PMID 23995064
RESULTRichebe P, Rivat C, Liu SS. Perioperative or postoperative nerve block for preventive analgesia: should we care about the timing of our regional anesthesia? Anesth Analg. 2013 May;116(5):969-970. doi: 10.1213/ANE.0b013e31828843c9. No abstract available. PMID 23606468
RESULTRichebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238. PMID 29738328