NCT01833728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

April 14, 2013

Last Update Submit

February 17, 2014

Conditions

Renal Tumor

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery

    Quality of recovery questionnaire score at 24 hours after surgery

    at 24 hours postoperative

Secondary Outcomes (1)

  • Postoperative opioid consumption

    at 24 and at 48 hours after surgery

Study Arms (2)

nefopam-propacetamol combination group

EXPERIMENTAL
Drug: nefopam-propacetamol combination

propacetamol alone group

ACTIVE COMPARATOR
Drug: propacetamol alone

Interventions

nefopam-propacetamol combinationDRUG

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.

nefopam-propacetamol combination group
propacetamol aloneDRUG

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.

propacetamol alone group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 11412156BACKGROUND

  • 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.

    PMID: 21226753BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

propacetamol

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2013

First Posted

April 17, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

KR(1)