Regional Anaesthesia and Substance P in Head and Neck Cancer

NCT03081897 | Suspended

• 1 other identifier: EA1/119/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Expression of Substance P

  2 years

Study Arms (2)

SPRANC Block group

EXPERIMENTAL

General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.

Drug: SPRANC Block group

SPRANC Control group

ACTIVE COMPARATOR

General anaesthesia

Drug: SPRANC Control group

Interventions

SPRANC Block group DRUG

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.

SPRANC Block group

SPRANC Control group DRUG

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.

SPRANC Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Lack of consent that pseudonomized data of the study may be saved and distributed

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Juergen Birnbaum, PD Dr

  Charité Universiteaetsmedizin Berlin, Klinik fuer Anaesthesiologie, Campus Mitte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine Berlin

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: March 16, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

DE (1)