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A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy

Primary Purpose

Renal Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nefopam-propacetamol combination
propacetamol alone
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Tumor

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA status 1-3,
  • aged 20 to 65 years,
  • undergoing laparoscopic nephrectomy

Exclusion Criteria:

  • Severe cardiac disease,
  • hepatic insufficiency,
  • chronic kidney disease stage ≥3,
  • preoperative use of analgesics(corticosteroids, opioid),
  • chronic alcoholics,
  • hemolytic anemia,
  • convulsions

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nefopam-propacetamol combination group

propacetamol alone group

Arm Description

Outcomes

Primary Outcome Measures

Quality of Recovery
Quality of recovery questionnaire score at 24 hours after surgery

Secondary Outcome Measures

Postoperative opioid consumption

Full Information

First Posted
April 14, 2013
Last Updated
February 17, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01833728
Brief Title
A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects. Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery. NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects. In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications. Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination. The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nefopam-propacetamol combination group
Arm Type
Experimental
Arm Title
propacetamol alone group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
nefopam-propacetamol combination
Intervention Description
Patients in both groups will receive intravenous patient-controlled analgesia (PCA) using fentanyl. In nefopam-propacetamol combination group, patients will receive nefopam(20mg mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
Intervention Type
Drug
Intervention Name(s)
propacetamol alone
Intervention Description
In propacetamol alone group, patients will receive placebo (normal saline 2 ml mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
Primary Outcome Measure Information:
Title
Quality of Recovery
Description
Quality of recovery questionnaire score at 24 hours after surgery
Time Frame
at 24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Time Frame
at 24 and at 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA status 1-3, aged 20 to 65 years, undergoing laparoscopic nephrectomy Exclusion Criteria: Severe cardiac disease, hepatic insufficiency, chronic kidney disease stage ≥3, preoperative use of analgesics(corticosteroids, opioid), chronic alcoholics, hemolytic anemia, convulsions
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
11412156
Citation
Mimoz O, Incagnoli P, Josse C, Gillon MC, Kuhlman L, Mirand A, Soilleux H, Fletcher D. Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection. Anaesthesia. 2001 Jun;56(6):520-5. doi: 10.1046/j.1365-2044.2001.01980.x.
Results Reference
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PubMed Identifier
21226753
Citation
Girard P, Niedergang B, Pansart Y, Coppe MC, Verleye M. Systematic evaluation of the nefopam-paracetamol combination in rodent models of antinociception. Clin Exp Pharmacol Physiol. 2011 Mar;38(3):170-8. doi: 10.1111/j.1440-1681.2011.05477.x.
Results Reference
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A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy

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