Laparotomy Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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