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Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nefopam 80mg/day
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
  • American Society of Anesthesiologists (ASA) physical classification I-II
  • Consent to IV-patient controlled analgesia use
  • Willingness and ability to sign an informed consent document

Exclusion Criteria:

  • Do not understand our study
  • Allergies to anesthetic or analgesic medications
  • Continuous local anesthetics infiltration for postoperative pain control
  • Patients who receive mechanical ventilation more than 2 hours after surgery
  • Pregnancy/Breast feeder
  • Medical or psychological disease that can affect the treatment response

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nefopam group

Control group

Arm Description

At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery, this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr.

The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr at the end of surgery.

Outcomes

Primary Outcome Measures

Total fentanyl consumption during 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

Total fentanyl consumption
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Postoperative pain score
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
chronic postsurgical pain
Incidence of chronic postsurgical pain (NRS ≥ 3) (%)

Full Information

First Posted
June 24, 2020
Last Updated
May 4, 2022
Sponsor
Seoul National University Hospital
Collaborators
Pharmbio Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04450355
Brief Title
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS
Official Title
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
August 9, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Pharmbio Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of intravenous nefopam can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.
Detailed Description
Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized double-blinded study
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes assessor not involved in this study will investigate the outcomes. The patient will be not informed of the infusion of nefopam by not attaching an identifiable label so that it cannot be distinguished from normal saline.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nefopam group
Arm Type
Experimental
Arm Description
At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery, this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Nefopam 80mg/day
Intervention Description
continuous nefopam infusion
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
continuous normal saline infusion
Primary Outcome Measure Information:
Title
Total fentanyl consumption during 24 hours
Description
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Total fentanyl consumption
Description
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time Frame
postoperative 48 hours
Title
Postoperative pain score
Description
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Time Frame
postoperative 24, 48 hours
Title
Postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting (%)
Time Frame
postoperative 24, 48 hours
Title
chronic postsurgical pain
Description
Incidence of chronic postsurgical pain (NRS ≥ 3) (%)
Time Frame
3-months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia American Society of Anesthesiologists (ASA) physical classification I-II Consent to IV-patient controlled analgesia use Willingness and ability to sign an informed consent document Exclusion Criteria: Do not understand our study Allergies to anesthetic or analgesic medications Continuous local anesthetics infiltration for postoperative pain control Patients who receive mechanical ventilation more than 2 hours after surgery Pregnancy/Breast feeder Medical or psychological disease that can affect the treatment response
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
KS013
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16368814
Citation
Tirault M, Derrode N, Clevenot D, Rolland D, Fletcher D, Debaene B. The effect of nefopam on morphine overconsumption induced by large-dose remifentanil during propofol anesthesia for major abdominal surgery. Anesth Analg. 2006 Jan;102(1):110-7. doi: 10.1213/01.ANE.0000181103.07170.15.
Results Reference
background
PubMed Identifier
14633755
Citation
Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, Fletcher D. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth. 2003 Dec;91(6):836-41. doi: 10.1093/bja/aeg264.
Results Reference
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Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS

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