LaparotomyPhase 2/3NCT02596269
Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia
A Phase 2/3 study testing Nefopam and Saline in people with Laparotomy, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Laparotomy
- What is being tested?
- Nefopam and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Sep 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- those planned for elective open laparotomy under general anesthesia, who were classified as ASA physical status I-II
Who cannot join
- 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
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Laparotomy
- Being tested
- Nefopam, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
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.
SalineDrug
i.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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), Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
fentanyl consumption
Measured: during the stay at PACU, at the end of intervention (24h after surgery)
Secondary outcomes (4)
pain intensity (NRS scores)
Measured: 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)
Measured: at the end of the study (24 h after the surgery)
hypertension, tachycardia, sweating, shivering, nausea, vomiting, sedation, pruritis and/or dry mouth
Measured: Throughout study on report-based (24h)
hypertension, tachycardia
Measured: 1h, 2h, 6h, 12h and 24h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmbio Korea Co., Ltd.
- Responsible party
- Principal investigator, Yong Chul Kim, Seoul National University Hospital
- Investigators
- Yong Chul Kim, MD., PhD., Principal investigator, Seoul National University Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596269
- Sponsor's protocol ID
- 1203-082-402
- Status last verified
- Nov 2015
- First submitted
- 23 Oct 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26047392Jin 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.
PubMed 27358262
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect and Safety of Intravenous Nefopam/Fentanyl Postoperative Patient-Controlled-Analgesia in Patients Undergoing Laparotomy
- ClinicalTrials.gov ID
- NCT02596269
- Acronym / sponsor ID
- 1203-082-402
- Conditions
- Laparotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Pharmbio Korea Co., Ltd.
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nefopam(NF) group | Experimental | Drug: NefopamReceived 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). |
| Saline(SF) group | Placebo comparator | Drug: SalineReceived i.v. PCA with 100 ml solution containing 1250 µg of fentanyl in normal saline (12.5 µg/ml), |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- those planned for elective open laparotomy under general anesthesia, who were classified as ASA physical status I-II
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nefopam120 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. | Drug | Nefopam(NF) group |
| Salinei.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time | Drug | Saline(SF) group |
Primary outcome
fentanyl consumption
Time frame: during the stay at PACU, at the end of intervention (24h after surgery)
4 secondary outcomes
pain intensity (NRS scores)
Time frame: 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)
hypertension, tachycardia, sweating, shivering, nausea, vomiting, sedation, pruritis and/or dry mouth
Time frame: Throughout study on report-based (24h)
hypertension, tachycardia
Time frame: 1h, 2h, 6h, 12h and 24h postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Background: PubMed 26047392Oh 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.
- Derived from this study: PubMed 27358262Jin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Chul Kim, MD., PhD. principal investigator
Seoul National University Hospital, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nefopam and Saline in people with Laparotomy, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fentanyl consumption (time frame: during the stay at PACU, at the end of intervention (24h after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596269, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.