Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia

NCT02596269 | Completed Phase 2 DMC

• 1 other identifier: 1203-082-402
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND : There has been increasing interest on the use of nefopam in i.v. patient-controlled analgesia (PCA). OBJECTIVE : The aim of this study was to evaluate the opioid-sparing effect of nefopam, when administered via i.v. PCA with fentanyl, after laparotomy. The adverse events associated with its use were also evaluated, and specific considerations in its clinical use were reviewed. DESIGN : A randomized, controlled, single-centre, double-blinded study. SETTING : One Korean university hospital. PATIENTS : Seventy-one patients planned for elective open laparotomy INTERVENTIONS : Patients were assigned into SF (control) or NF group, who received IV PCA with fentanyl in normal saline (25 µg/ml), or a solution with 120 mg of nefopam included (fentanyl 25 µg/ml and nefopam 1.2 mg/ml), respectively. MAIN OUTCOME MEASURES : The pain intensity during the 24 h study period and patient satisfaction at the end of the study were evaluated. Adverse events were observed.

Conditions

Laparotomy

Outcome Measures

Primary Outcomes (1)

• fentanyl consumption

  during the stay at PACU, at the end of intervention (24h after surgery)

Secondary Outcomes (4)

• pain intensity (NRS scores)

  1h, 2h, 6h, 12h and 24h postoperatively

• Satisfaction on analgesia using 4-points VRS (0: no satisfaction, 1: mild satisfaction, 2: moderate satisfaction, and 3: intense satisfaction)

  at the end of the study (24 h after the surgery)

• hypertension, tachycardia, sweating, shivering, nausea, vomiting, sedation, pruritis and/or dry mouth

  Throughout study on report-based (24h)

• hypertension, tachycardia

  1h, 2h, 6h, 12h and 24h postoperatively

Study Arms (2)

Nefopam(NF) group

EXPERIMENTAL

Received i.v. PCA with the same volume of solution containing 1250 µg fentanyl plus 120 mg of nefopam in normal saline (fentanyl 12.5 µg/ml and nefopam 1.2 mg/ml).

Drug: Nefopam

Saline(SF) group

PLACEBO COMPARATOR

Received i.v. PCA with 100 ml solution containing 1250 µg of fentanyl in normal saline (12.5 µg/ml),

Drug: Saline

Interventions

Nefopam DRUG

120 mg of nefopam is included in the i.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time was set, without any background continuous infusion. After the end of surgery, and if the goal VRS score was achieved at PACU, PCA device was turned on and the patient was encouraged to use the pre-set bolus dose, until 24h after the end of surgery.

Nefopam(NF) group

Saline DRUG

i.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time

Saline(SF) group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• those planned for elective open laparotomy under general anesthesia, who were classified as ASA physical status I-II

You may not qualify if:

• the presence of renal and hepatic disease, high risk of urinary retention, seizure history, known allergy to any of the medications used, current history of psychiatric disorder, or those presently taking psychotropic medications or monoamine oxidase inhibitors.
• Patients who could not understand verbal rating scale (VRS) and 11-points numeric rating scale (NRS) pain scores, or did not sign on informed consent

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Pharmbio Korea Co., Ltd.: collaborator

Related Publications (2)

• Oh CS, Jung E, Lee SJ, Kim SH. Effect of nefopam- versus fentanyl-based patient-controlled analgesia on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: a prospective double-blind randomized controlled trial. Curr Med Res Opin. 2015 Aug;31(8):1599-607. doi: 10.1185/03007995.2015.1058251. Epub 2015 Jul 9.

  PMID: 26047392 BACKGROUND

• Jin HS, Kim YC, Yoo Y, Lee C, Cho CW, Kim WJ. Opioid sparing effect and safety of nefopam in patient controlled analgesia after laparotomy: A randomized, double blind study. J Int Med Res. 2016 Aug;44(4):844-54. doi: 10.1177/0300060516650783. Epub 2016 Jun 29.

  PMID: 27358262 DERIVED

MeSH Terms

Interventions

Nefopam; Sodium Chloride

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yong Chul Kim, MD., PhD.

  Seoul National University Hospital, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 4, 2015
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 5, 2015

Record last verified: 2015-11