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

Video-Assisted Thoracoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980835
• Other study ID #: 721921
• Status: Completed
• Phase: Phase 4
• Start date: September 28, 2016
• Est. completion date: March 30, 2022

Study information

• Verified date: September 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The design of the study is a double-blind, prospective, multi-center, randomized, controlled clinical trial of preemptive vs. post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy (VATS) pain. In standard intercostal nerve block procedures, the contents 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) 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) are combined into one set of injections injected into the intercostal spaces of T5-6, T6-7, T7-8, T8-9 and T9-10, with each intercostal spaces receives about 7 mL of combined A and C solutions (each intercostal space receives 2 mL of A and about 5 mL of C). In this study, the intercostal nerve block is split into two sets of injections: one set of injections at the beginning of VATS, and the other set right before closure. Therefore the investigators consider both sets of injections as research procedures. Patients will be randomly assigned to receive a preemptive 2mL-injection of A or injection of B (contains 10 mL of 0.9% normal saline) at each intercostal space as previously delineated by the operating surgeon. Both the research team and the surgical team will be blind to the nature of the injectates during surgery. As parts of the standard care procedures, all patients will be monitored with non-invasive ASA standard in addition to invasive arterial blood pressure monitoring. Prior to the closure, patients who receive injections of A at the beginning of surgery will receive the second set of injections containing a mixture of B and C (5 mL of solution C is given at each intercostal space) at the intercostal spaces as previously delineated. Patients who receive injections of B at the beginning of surgery will receive the second set of injections containing a mixture of A and C (5 mL of solution C is given at each intercostal space). The investigators will group the patients who are assigned to receive injectate A at the end of the surgery as the control group. Because the injectate A and injectate C are usually given together in one set of injections at the same anatomical locations in standard intercostal nerve block procedures, the intercostal block received by the control group will closely resemble the procedures performed in standard intercostal nerve block. Patients who receive injectate A at the beginning of surgery are grouped as experimental group. Regardless of the group assignment, the total dosage of ropivacaine and dexamethasone given to a patient will be equal to the dosage given under the standard care procedures. Post operative pain, ventilatory profile and length of hospital stay will be compared between two study arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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 Exclusion Criteria:

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).

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Video-Assisted Thoracic Surgery
• Video-Assisted Thoracoscopic Surgery

Intervention

Drug:
• Normal Saline
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.
• Ropivacaine
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.
• Epinephrine
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.
• Dexamethasone
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.

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	The VA Western New York Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)	Postoperative delirium profiles will be measured 12 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)	12 hours
Secondary	Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)	Postoperative delirium profiles will be measured 24 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)	24 hours
Secondary	Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)	Postoperative delirium profiles will be measured 36 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)	36 hours
Secondary	Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)	Postoperative delirium profiles will be measured 48 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)	48 hours
Secondary	PaO2/FIO2 ratio right after surgery	PaO2 (mmHg kPa) and FIO2 (percent) will be recorded from atrial blood gas examination and the ratio will be calculated	0 hours
Secondary	Total hospital length of stay	The investigators will assess length of stay by evaluating medical records and calculate length of stay in days, using date of discharge and date of admission	up to 2 weeks
Secondary	Need for non-invasive positive pressure ventilation (NIPPV)	The investigators will assess the need for NIPPV by evaluating medical records to asses if patients received NIPPV with the discretion of the managing physician during their hospitalization	up to two weeks
Secondary	Need for mechanical ventilation	The investigators will assess the need for mechanical ventilation by evaluating medical records to asses if patients received mechanical ventilation with the discretion of the managing physician during their hospitalization	up to two weeks