Regional Anaesthesia and Substance P in Head and Neck Cancer (SPRANC)

Influence of Regional Anaesthesia on the Expression of Substance P During Unilateral Neck Dissection Due to Head and Neck Cancer

In the clinical trial the investigators will observe the impact of regional anesthesia in addition to a general anesthesia on the expression of substance P in patients with unilateral Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side will be analysed by immunohistology, measuring the expression of the Substance P.

Study Overview

• Status: Suspended
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: SPRANC Block group; Drug: SPRANC Control group

Detailed Description

Several investigations show that anesthetic procedures, and especially the perioperative regional anesthesia, can have a benefit for patients undergoing tumor surgery.The perioperative regional anesthesia might reduce the immunological response and therefore lower the risk of tumor relapse. Factors that might play a role in tumor relapse are various, so more prospective and randomised trials are necessary to investigate the underlying mechanisms.

In a retrospective analysis by Merquiol et al. it was shown that an cervical epidural anesthesia was associated with an extended tumorfree timeline of larynx and hypopharynx carcinoma.

Supporting results could be seen in a study by Munoz et al. performing regional anaesthesia in breast cancer patients.

Taking all these facts into consideration the investigators believe that performing regional aneasthesia could reduce the relapse of larynx carcinoma. The relapse of carcinoma is believed to be linked to substance P and the neurokinin 1 (NK-1) receptor .

It is accepted that an additional regional anesthesia could reduce the impact of substance P to gain a normal immune response in the perioperative setting and to reduce the rate of tumor relapse.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients at Charité - Universitaetsmedizin Berlin, Campus Charité Mitte
• Primary diagnosis of unilateral head or neck cancer
• Resection of Tumor is planned with unilateral neck dissection
• Patient did not underwent any therapeutic treatment of the cancer before start of study
• Surgical therapy is planned with curative intent

Exclusion Criteria:

• Allergy to local anesthetics
• Coagulation disorders, which can lead to complications in regional anesthesia
• Insulin-dependent diabetes mellitus, polyneuropathy
• Severe psychiatric disorders
• Dementia
• Alcohol abuse, Korsakoff syndrome
• Medication with immunosuppressants or immune modulantia
• Patient under Special Care
• Refusal of study participation
• Pregnancy and breast feeding period.
• Participation in a clinical intervention study, parallel with the study or participation up to 30 days before inclusion
• Lack of consent that pseudonomized data of the study may be saved and distributed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPRANC Block group; General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.	Drug: SPRANC Block group; General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); additional regional anaesthesia (cervical plexus block) with an long acting local anesthetic according to clinical estimation of the treating anesthetist (about 15 ml Ropivacaine 0,75% around the carotid bifurcation, 5 ml Ropivacaine in the region of Erb´s Point of the superficial cervical plexus and 10 ml Ropivacaine at the area of skin incision on the tumor side); unilateral neck dissection.
Active Comparator: SPRANC Control group; General anaesthesia	Drug: SPRANC Control group; General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); additional regional Patient Control Group (no Intervention planned), general anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); unilateral neck dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expression of Substance P	2 years

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Juergen Birnbaum, PD Dr, Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: EA1/119/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED