Postoperative Pain Clinical Trial
Official title:
Dexamethasone Improves Postoperative Symptoms in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Randomised Clinical Trial.
Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after
laparoscopic cholecystectomy (LC). However, its effects on other surgical outcomes such as
pain and fatigue have been unclear. We evaluated the efficacy of preoperative dexamethasone
in ameliorating postoperative symptoms after LC.
Methods: Prospective, double-blind, placebo-controlled study, 210 patients scheduled for
elective LC were analyzed after randomization to intravenous dexamethasone (8 mg) or to a
placebo. All patients underwent standardized procedures for general anesthesia and surgery.
Episodes of PONV and pain and fatigue scores were recorded on a visual analogue scale.
Analgesic and antiemetic requirements were also recorded.
Patients and methods
Patients Between January 2007 and August 2008, 210 patients undergoing LC were studied in
accordance with a prospective, randomized, double-blind clinical trial. Patients were
randomized to receive intravenous dexamethasone (8 mg) or homologated placebo 60 minutes
before skin incisions, using an equal number of blind envelopes. Patients of American Society
of Anesthesiologists (ASA) classes III and IV were excluded. Further exclusion criteria were
age more than 80 years; pregnancy; treatment with steroids; severe diabetes mellitus (HbA1c >
8%); use of opioids, sedatives or any kind of analgesics less than one week before LC; a
history of alcohol or drug abuse; preoperative diagnosis of acute cholecystitis, acute
pancreatitis, choledocolithiasis, gallbladder carcinoma and/or conversion of the LC to an
open procedure. All patients were followed from hospital admission until 30 days after the
surgical procedure.
Anesthesia and surgery All patients underwent a standardized general anesthesia procedure.
Induction used intravenous midazolam (1.5 mg) and fentanyl (3-5 mcg/kg of body weight) and
propofol (2 mg/kg body weight). Anesthesia was maintained with 2 to 3% sevoflurane and 100%
oxygen concentration. Neuromuscular blocking was maintained with intravenous vecuronium (0.1
mg/kg body weight). All patients were monitored with indirect determinations of arterial
pressure and heart rate using the standard technique as well as expired CO2 content and
oxygen blood saturation. A nasogastric tube was placed in all patients during the operation
and taken out at the end of the surgical procedure. Afterwards, all patients were extubated
and transferred to the immediate postsurgical care unit with cardiovascular and oxygen
monitoring.
All patients received preoperative intravenous antibiotics (1 g of intravenous
first-generation cephalosporin). LC was performed using a 2-handed, 4-trocar technique with 2
10-mm ports and 2 5-mm ports. A 10-mm subumbilical port was introduced by the open method,
subsequently creating a pneumoperitoneum, maintained at 12 to 14 mmHg of intra-abdominal
pressure. All of the laparoscopic treatments were performed by expert surgeons, each having
sufficient experience of laparoscopic surgery (more than 150 LCs per year). The skin was
closed with single nonabsorbable sutures. Closed suction drains were placed in the inferior
surface of the liver, using a 5-mm lateral port in some patients according to each surgeon's
preference. The drains were removed during the following 12-24 h.
Analgesia and antiemetics Pain and fatigue were assessed preoperatively and immediately on
return to the recovery room, and at 6, 12 and 24 h after the operation using a visual
analogue scale (VAS; 0 = no pain/fatigue to 10 = most severe pain/fatigue) [7,15,16].
Analgesia was given as intravenous sodium ketorolac (30 mg every 8 h). Intramuscular
buprenorphine (0.15-0.30 mcg) was used as a backup analgesic medication. The incidence of
PONV was recorded immediately on return to the recovery room and at 6, 12 and 24 h, after the
operation, using a four-point ordinal scale (0 = none, 1 = nausea, 2 = nausea with request
for antiemetic, 3 = vomiting). Intravenous ondansetron (4-8 mg) was given for antiemetic
treatment on demand.
Data collection and statistical analysis Postoperative complications were recorded during
hospitalization and the patients were followed up to 30 days after discharge. Data collected
also included patient age, sex, body mass index (BMI), ASA score, history of previous
abdominal surgery, anesthesia and operation time and frequency of use of analgesic and
antiemetic drugs. These parameters were summed and compared between the dexamethasone and
placebo groups. The study endpoints were degree of postoperative nausea, vomiting, pain and
fatigue and additional analgesic and antiemetic drugs.
The sample size was predetermined. We expected a 20% difference in the incidence of nausea
and vomiting between groups. The error alpha error was set at 0.05 and beta error at 0.20; n
= 103 patients for each group was considered adequate, according to a power analysis. Results
were expressed as percentages and as the mean ± standard deviation (SD). Student's t test and
the chi squared test were used for the analysis of quantitative and qualitative data,
respectively. Differences were considered statistically significant at p < 0.05.
Ethical considerations The study was conducted according to the principles of the Declaration
of Helsinki of 1989 and the Mexican Health Guidelines. The Ethical and Research Committees of
the Regional Hospital # 110 of the Mexican Institute for Social Security in Jalisco, Mexico
approved all protocols. Full, written informed consent was obtained from all patients before
their inclusion in the study.
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