Page 25 - Journal of Laparoscopic Surgery - WALS Journal
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WJOLS
Ropivacaine Hydrochloride Instillation vs Parenteral Analgesia (Tramadol)
I and II, scheduled to undergo elective laparoscopic RESULTS
cholecystectomy, were enrolled in this study, which was After obtaining written consent, 400 patients with
approved by the hospital ethics committee. Patients were American Society of Anesthesiologists physical status
excluded if they had clinical diagnosis of acute pancreatitis, I and II, who were scheduled to undergo elective
had acute preoperative pain other than biliary colic, laparoscopic cholecystectomy, were included in this
required chronic pain treatment or antiepileptic drugs, study. No significant difference between both groups as
had history of alcohol or drug addiction, had severe hepatic regarding their age and sex ratio was observed (Table 1).
or renal impairment, had allergy to the study drugs, or During the early postoperative assessment of pain, the
had cognitive impairment or communication problems score on the VAS scale was highly significantly lower in
[i.e., who did not understand visual analog scale (VAS)]. group I than in group II just immediately postoperative
Preanesthetic check-up was done the day before in the recovery area and remained significant till 4 hours
surgery and included a detailed history and complete postoperatively. After 4 hours, there was no significant
general physical and systemic examination. Baseline difference between both groups (Table 2).
values of pulse, blood pressure, and respiratory rate The timing of first dose of rescue analgesia needed
were recorded. Basic demographic characteristics like was significantly longer in group I than in group II.
age, sex, and weight were noted. Routine investigations Also the dose of nonsteroidal anti-inflammatory drugs
included hemoglobin, clotting time, bleeding time, X-ray (NSAIDs, in mg) needed as rescue analgesia was signifi-
chest, electrocardiogram, renal function tests, serum cantly lower in group I than in group II. Also shoulder pain
electrolytes, blood glucose level, and liver function was significantly lower in group I than in group II (Table 3).
tests. Patients were kept fasting overnight and were Table 1: Age and sex of both groups
premedicated with tablet diazepam 10 mg at bed time. Group I Group II
At the same visit (preanesthetic check-up) patients (n = 200) (n = 200)
were instructed on how to use a 100-cm VAS, with Age (years) Mean range 27.51 years 29.07 years
anchors ranging from “no pain” to “worst possible pain.” (min-max) 18–65 years 21–64 years
Patients were randomized into two groups using a Sex Male: Female 71:129 (1:2) 64:146 (1:2)
computer-generated randomization sequence. Patients in Ratio
the instillation group (Group I) received intraperitoneal Table 2: Postoperative visual analog scale for patients in both groups
instillation of ropivacaine 0.5%, 10 ml (50 mg) on the
gallbladder surgical bed, and ropivacaine 0.5%, 10 ml I VAS ≤ 40 I VAS < 40 p-value
II
II
(50 mg) solution was sprayed on the upper surface of the Immediate 169 66 31 134 HS
liver and on right subdiaphragmatic space, to allow it to postoperative
diffuse into the hepatodiaphragmatic space, near and After 1 hour 157 98 43 102 S
above the hepatoduodenal ligament and above gallblad- After 2 hours 152 107 48 93 S
der before finishing the procedure. This was done using After 3 hours 145 112 55 88 S
a catheter inserted into the subcostal trocar under direct After 4 hours 124 119 76 81 NS
laparoscopic control and the patient was kept in the Tren- After 8 hours 132 135 68 65 NS
56
NS
49
144
141
After 12 hours
delenburg position. In addition, each four-portal site was After 16 hours 159 163 41 37 NS
infiltrated with ropivacaine 0.3%, 3 ml after completion of After 20 hours 171 170 29 30 NS
the surgery. Patients in group II received 100 mg tramadol After 24 hours 181 178 19 22 NS
intramuscularly (IM) at the end of procedure. HS: Highly significant; S: Significant; NS: Nonsignificant; VAS:
The degree of postoperative pain was assessed using Visual analog score
VAS in case of spontaneous pain upon patient’s arrival Table 3: Shoulder pain postoperative analgesia for both groups
in the recovery room, immediately postoperatively, and
thereafter every 1 hour for a period of first 4 hours then Group I Group II p-value
every 4 hours for the rest of the first 24 hours postopera- Shoulder pain 47 (23.5%) 117 (58.5%) S
S
16 ±
Mean timing after surgery 115 ±
tively. Shoulder pain was evaluated at immediate postop- to give first analgesic 38.36 min 9.43 min
erative time, and at 12 and 24 hours from the termination requirement (in minutes)
of surgery. Those patients with VAS more than 40 were ± SD 2
administered diclofenac sodium 75 mg IM as rescue anal- No. of Min–Max 75–150 mg 75–225 mg S
NSAIDs
gesia. Time to first analgesic requirement, total analgesic Mean 45 ± 10.5 mg 85 ± 25.2 mg
consumption in the first 12 hours postoperatively, and S: Significant; SD: Standard deviation; NSAID: Nonsteroidal
occurrence of adverse events were also recorded. anti-inflammatory drug
World Journal of Laparoscopic Surgery, January-April 2016;9(1):25-25 23