Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia
Condition: Laparotomy
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Nefopam; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 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.; i.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment