Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries

NCT02980835 | Completed Phase 4 FDA Drug

• 1 other identifier: 721921
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Intercostal nerve block, performed under the guidance of videoscope, is a part of standard anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this double-blind, prospective, multi-center, randomized, controlled clinical trial the investigators aim to compare preemptive versus post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy pain.

Conditions

Video-Assisted Thoracic Surgery; Video-Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (7)

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded right after surgery and compared in both groups

  0

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded 6 hours after surgery and compared in both groups

  6 hours

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded 12 hours after surgery and compared in both groups

  12 hours

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded 18 hours after surgery and compared in both groups

  18 hours

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded 24 hours after surgery and compared in both groups

  24 hours

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded 48 hours after surgery and compared in both groups

  48 hours

• Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score

  VAS scores at rest will be recorded 72 hours after surgery and compared in both groups

  72 hours

Secondary Outcomes (8)

• Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)

  12 hours

• Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)

  24 hours

• Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)

  36 hours

• Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)

  48 hours

• PaO2/FIO2 ratio right after surgery

  0 hours

Study Arms (2)

Intervention

EXPERIMENTAL

Patients who receive injections of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) at the beginning of surgery and second set of injections containing a mixture of B (contains 10 mL of 0.9% normal saline) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) prior to the closure

Drug: Normal Saline; Drug: Ropivacaine; Drug: Epinephrine; Drug: Dexamethasone

Control

ACTIVE COMPARATOR

Participants who receive injection of B (contains 10 mL of 0.9% normal saline) at the beginning of surgery and injectate A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and injectate C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) at the end of procedure prior to the closure (which mimics standard care) is the control group

Drug: Normal Saline; Drug: Ropivacaine; Drug: Epinephrine; Drug: Dexamethasone

Interventions

Normal Saline DRUG

Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.

Control; Intervention

Ropivacaine DRUG

Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.

Control; Intervention

Epinephrine DRUG

Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.

Control; Intervention

Dexamethasone DRUG

Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible to enroll in this study if they:
• Have physical status within ASA class II or III
• Are between 18 and 85 years of age
• Are candidates for VATS
• Are able to complete VAS assessments
• Are competent to sign the informed consent form

You may not qualify if:

• Patients will not be enrolled in this study if they:
• Are pregnant
• Have allergy to ropivacaine or hydromorphone
• Have renal insufficiency (eGFR\<60mL/min/1.73m2)
• Have hepatic insufficiency (AST, ALT, or both \>60 U/L) or cirrhosis
• Have a predicted postoperative forced vital capacity (FVC) of \<40%, predicted forced expiratory volume at 1s (FEV1) \<40%
• Have coagulopathy (platelet count\<50000, INR\>2, or both)
• Have a history of opioid addiction, chronically taking opioids, currently taking high dose of opioids or currently taking opioid agonist+antagonist (e.g. Suboxone®)
• Are taking nonsteroidal anti-inflammatory drug, including aspirin, within a week prior to surgery (since the analgesic effects of NSAID drugs may become confounding factors).

Sponsors & Collaborators

• University at Buffalo: lead
• The VA Western New York Healthcare System: collaborator

Study Sites (1)

VA Western New York Healthcare System

Buffalo, New York, 14215, United States

Location

MeSH Terms

Interventions

Saline Solution; Ropivacaine; Epinephrine; Dexamethasone

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Vice Chair

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 2, 2016
• Study Start: September 28, 2016
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)