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

Yonsei University logo

Yonsei University

Status

Completed

Conditions

Renal Tumor

Treatments

Drug: propacetamol alone
Drug: nefopam-propacetamol combination

Study type

Interventional

Funder types

Other

Identifiers

NCT01833728
4-2013-0023

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 2 patient groups

nefopam-propacetamol combination group
Experimental group
Treatment:
Drug: nefopam-propacetamol combination
propacetamol alone group
Active Comparator group
Treatment:
Drug: propacetamol alone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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