Skip to main content
OpenTrials
Completed

NCT Number: NCT01833728

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nefopam-propacetamol combination

Drug

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.

propacetamol alone

Drug

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 outcomes

  1. Quality of Recovery

    Time frame: at 24 hours postoperative

    Quality of recovery questionnaire score at 24 hours after surgery

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: at 24 and at 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2013
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.