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

Not Applicable

Completed

• Conditions: Renal Tumor
• Interventions: Drug: nefopam-propacetamol combination; Drug: propacetamol alone

• Registration Number: NCT01833728
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-14
• Study First Posted: 2013-04-17
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nefopam-propacetamol combination group	nefopam-propacetamol combination	-
propacetamol alone group	propacetamol alone	-

Primary Outcome Measures

Name	Time	Method
Quality of Recovery	at 24 hours postoperative	Quality of recovery questionnaire score at 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	at 24 and at 48 hours after surgery

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of