- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02596269
Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia
A Randomized Controlled Trial on the Effect and Safety of Intravenous Nefopam/Fentanyl Postoperative Patient-Controlled-Analgesia in Patients Undergoing Laparotomy
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.
Study Overview
Detailed Description
Patients included were those planned for elective open laparotomy under general anesthesia, who were classified as American Society of Anesthesiologists (ASA) physical status I-II, with ages from 20 to 65 years.
A computer-generated randomization table was used to allocate patients equally into two groups, saline-fentanyl (SF) group (n=36) and Nefopam-fentanyl (NF) group (n=36). SF group, the control group received i.v. PCA with 100 ml solution containing 1250 µg of fentanyl in normal saline (12.5 µg/ml), while NF group, 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). For both groups, a bolus of 1 ml with an 8-min lockout time was set, without any background continuous infusion during the study period.
After the end of surgery, as soon as the patient was awake, the pain intensity was assessed using the 4-points verbal rating scale (VRS) score (0: no pain, 1: mild pain, 2: moderate pain, and 3: intense pain), at 5-min interval, while staying at PACU. The pain was assessed at rest (VRS-R). If the patient reported VRS-R ≥ 3, an anesthetist not involved in the study administered a rescue dose of IV fentanyl 1 µg/kg. Then, pain was assessed every 5 min, and fentanyl given until VRS-R < 3. If the score did not fall below 3 despite 5 times of bolus fentanyl administration (30 min after arrival on PACU), the patient was dropped out of the study.
If the goal VRS score was achieved, PCA device was turned on and the patient was encouraged to use the pre-set bolus doses.
After the 30 min stay at PACU, the patients were transferred to the ward, and both numeric rating scale (NRS) pain score at rest (NRS-R) and on coughing (NRS-C) using an NRS (0-10), were recorded at 1h, 2h, 6h, 12h and 24h postoperatively. The data of cumulative PCA dose and the number of bolus doses, as displayed on the PCA device, were recorded and transferred to a computer for interpretation. No additional analgesics, antipyretics, or anti-inflammatory drug were allowed during the study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- those planned for elective open laparotomy under general anesthesia, who were classified as ASA physical status I-II
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nefopam(NF) group
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).
|
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.
|
Placebo Comparator: Saline(SF) group
Received i.v.
PCA with 100 ml solution containing 1250 µg of fentanyl in normal saline (12.5 µg/ml),
|
i.v.
PCA with with 100 ml solution containing 1250 µg fentanyl.
a bolus of 1 ml with an 8-min lockout time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fentanyl consumption
Time Frame: during the stay at PACU, at the end of intervention (24h after surgery)
|
during the stay at PACU, at the end of intervention (24h after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain intensity (NRS scores)
Time Frame: 1h, 2h, 6h, 12h and 24h postoperatively
|
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)
Time Frame: at the end of the study (24 h after the surgery)
|
at the end of the study (24 h after the surgery)
|
hypertension, tachycardia, sweating, shivering, nausea, vomiting, sedation, pruritis and/or dry mouth
Time Frame: Throughout study on report-based (24h)
|
Throughout study on report-based (24h)
|
hypertension, tachycardia
Time Frame: 1h, 2h, 6h, 12h and 24h postoperatively
|
1h, 2h, 6h, 12h and 24h postoperatively
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yong Chul Kim, MD., PhD., Seoul National University Hospital, Korea
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1203-082-402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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