scholarly journals Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial

Medicina ◽  
2021 ◽  
Vol 57 (4) ◽  
pp. 316
Author(s):  
Ki Tae Jung ◽  
Keum Young So ◽  
Seung Chul Kim ◽  
Sang Hun Kim

Background and Objectives: We investigated the non-inferiority of patient-controlled analgesia (PCA), using either nefopam alone or combined nefopam-fentanyl for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Materials and Methods: In this prospective, randomized, controlled study, 78 patients were allocated to receive nefopam 240 mg (Group N240) or nefopam 120 mg with fentanyl 600 μg (Group NF), equivalent to fentanyl 1200 μg, with a total PCA volume of 120 mL. Patients were given a loading dose (0.1 mL/kg) from the PCA device along with ramosetron (0.3 mg) and connected to a PCA device with a background infusion rate of 2 mL/h, bolus dose amount set at 2 mL, and lockout interval set at 15 min. Pain scores were obtained using the numeric rating scale (NRS) at 30 min after recovery room (RR) admission, as well as 8 and 24 h postoperatively. The primary outcome was analgesic efficacy evaluated using NRS-rated 8 h postoperatively. Other evaluated outcomes included the incidence rate of bolus demand, rescue analgesic and antiemetic requirements, and postoperative adverse effects. Results: NRS scores were not significantly different between the groups throughout the postoperative period (p = 0.539). NRS scores of group N240 were not inferior to those of group NF at 30 min after RR admission, or at 8 and 24 h postoperatively (mean difference [95% CI], −0.05 [−0.73 to 0.63], 0.10 [−0.29 to 0.50], and 0.28 [−0.06 to 0.62], respectively). Postoperative adverse effects were not significantly different between the two groups (p = 1.000) and other outcomes were also not significantly different between the two groups (p ≥ 0.225). Conclusions: PCA using nefopam alone has a non-inferior and effective analgesic efficacy and produces a lower incidence of postoperative adverse effects compared to a combination of fentanyl and nefopam after laparoscopic cholecystectomy.

Author(s):  
Ki Tae Jung ◽  
Keum Young So ◽  
Seung Un Kim ◽  
Sang Hun Kim

Background and objectives: Traditional intravenous, patient-controlled analgesia (PCA) uses a fixed-rate continuous background infusion mode. However, some patients suffer from inadequate analgesia or opioid-related adverse effects due to the biphasic pattern of postoperative pain. Therefore, we investigated the postoperative analgesic efficacy of PCA using an optimizing background infusion mode (OBIM), where the background injection rate varies depending on the patient's bolus demand. Materials and Methods: We prospectively enrolled 204 patients who underwent laparoscopic cholecystectomy in a randomized, controlled, double-blind study. Patients were allocated into either the optimizing (group OBIM) or the traditional background infusion group (group TBIM). The numeric rating scale (NRS) score for pain was evaluated at admission to and discharge from the recovery room, as well as at the 6th, 24th, and 48th postoperative hours. Data of bolus demand count, total infused volume, and background infusion rate was downloaded from the PCA device at 30-min intervals until the 48th postoperative hour. Results: The NRS score was not significantly different between groups throughout the postoperative period (P = 0.621), decreasing with time in both groups (P < 0.001). The bolus demand count was not significantly different between groups throughout (P = 0.756). The mean cumulative infused PCA volume was lower in group OBIM [84.0 (95% confidence interval: 78.9−89.1) mL) than in group TBIM [102 (97.8−106.0) mL] (P < 0.001). The background infusion rate was significantly different between groups throughout (P < 0.001); it was higher in group OBIM than in group TBIM before the 12th postoperative hour, and lower from the 18th to the 48th postoperative hours. Conclusions: The OBIM combined with bolus dosing is useful in that it reduces the cumulative PCA volume compared to the TBIM combined with bolus dosing, while yielding comparable postoperative analgesia and bolus demand in patients undergoing laparoscopic cholecystectomy.


2006 ◽  
Vol 105 (5) ◽  
pp. 1016-1023 ◽  
Author(s):  
Andreas Tröster ◽  
Ruth Sittl ◽  
Boris Singler ◽  
Martin Schmelz ◽  
Jürgen Schüttler ◽  
...  

Background Numerous experimental and clinical studies suggest that brief opioid exposure can enhance pain sensitivity. It is suggested that spinal cyclooxygenase activity may contribute to the development and expression of opioid tolerance. The aim of the investigation was to determine analgesic and antihyperalgesic properties of the cyclooxygenase-2 inhibitor parecoxib on remifentanil-induced hypersensitivity in humans. Methods Fifteen healthy male volunteers were enrolled in this randomized, double-blind, placebo-controlled study in a crossover design. Transcutaneous electrical stimulation at high current densities was used to induce spontaneous acute pain (numeric rating scale 6 of 10) and stable areas of pinprick hyperalgesia. Pain intensities and areas of hyperalgesia were assessed before, during, and after a 30-min intravenous infusion of remifentanil (0.1 microg x kg x min) or placebo (saline). Parecoxib (40 mg) was administered intravenously either with onset of electrical stimulation (preventive) or in parallel to the remifentanil infusion. Results Remifentanil reduced pain and mechanical hyperalgesia during the infusion, but upon withdrawal, pain and hyperalgesia increased significantly above control level. Preventive administration of parecoxib led to an amplification of remifentanil-induced antinociceptive effects during the infusion (71.3 +/- 7 vs. 46.4 +/- 17% of control) and significantly diminished the hyperalgesic response after withdrawal. In contrast, parallel administration of parecoxib did not show any modulatory effects on remifentanil-induced hyperalgesia. Conclusion The results confirm clinically relevant interaction of mu opioids and prostaglandins in humans. Adequate timing seems to be of particular importance for the antihyperalgesic effect of cyclooxygenase-2 inhibitors.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Siddhartha Handa ◽  
MS Sangolli ◽  
Sanjay Panchal

Abstract Aim To study the effectiveness of intraperitoneal instillation of tramadol for postoperative laparoscopic cholecystectomy (LC) pain relief and improve incidence of adverse effect. Methods Double blinded randomized controlled trial over 1 year. The Ethical Clearance was obtained from Institutional Ethics Committee. 60 patients scheduled for LC were enrolled in the study. Patients were randomly assigned into 2 groups using computer generated random numbers. Group T: Received intraperitoneal tramadol 100 mg (diluted in 20 mls distilled water). Group S: Received 20 ml of intraperitoneal normal saline. Pain was assessed using VAS. The assessment was done at 0, 15, 30, 60 minutes, 4, 8, 12, 16 and 24 hours. Incidence of adverse effect were observed. Results In group T, the mean pain scores at all the intervals were significantly low (p < 0.050) except at 24 hours (p = 0.210). Analgesia requirement was significantly high in group S compared to group T immediate post op, 15, 60 minutes, 8 and 12 hours (p < 0.050). The mean requirement of analgesia immediate post op, 15 minutes, 4 and 8 hours was significantly low in group T compared to group S (p < 0.050). 30% patients in group T did not require analgesia at all compared to S (p < 0.001). Incidence of adverse effects at 4 hours was 43% in group S compared to 40% in group T (p > 0.050). Conclusion Intraperitoneal instillation of tramadol in LC has beneficial effect in terms of postoperative pain relief following LC and lower requirement of analgesia. However, the incidence of adverse effects was comparable in both the groups.


2019 ◽  
Vol 96 (1140) ◽  
pp. 606-609
Author(s):  
Mithun V Valappil ◽  
Sumit Gulati ◽  
Manish Chhabra ◽  
Ajay Mandal ◽  
Sanjay De Bakshi ◽  
...  

BackgroundThere is paucity of evidence regarding the role of drain in laparoscopic cholecystectomy (LC) in acute calculous cholecystitis (ACC), and surgeons have placed the drains based on their experiences, not on evidence-based guidelines. This study aims to assess the value of drain in LC for ACC in a randomised controlled prospective study.Patients and methodsAll patients with mild and moderate ACC undergoing LC were assessed. Preoperatively, patients with choledocholithiasis, Mirizzi syndrome and biliary stent were excluded. Intraoperatively or postoperatively, patients with complications, partial cholecystectomies and malignancies were excluded. Patients were randomised using computer-generated random numbers into two groups at the end of cholecystectomy before closure. Requirement of radiologically guided (ultrasonography () or CT) percutaneous aspiration/drainage of symptomatic intra-abdominal collection or reoperation; continuation of parenteral antibiotics beyond 24 hours or change in antibiotics empirically or based on peritoneal fluid culture sensitivity; requirement of postoperative USG or CT scan based on postoperative clinical course; wound infection rates; postoperative pain using numeric rating scale at 6 and 24 hours; and the duration of hospital stay in both groups were noted.ResultsForty-two out of 50 consecutive patients were randomised into two equal groups. Pain score at 6 and 24 hours was less in patients without drain. All other complication rates and duration of stay were similar in both groups.ConclusionsDrains should not be placed routinely after LC in ACC as it increases pain and does not help in detecting or decreasing complications.


Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 42
Author(s):  
Ki Tae Jung ◽  
Keum Young So ◽  
Seung Un Kim ◽  
Sang Hun Kim

Background and objectives: The fixed-rate continuous background infusion mode with bolus dosing is a common modality for intravenous patient-controlled analgesia (PCA). However, some patients suffer from inadequate analgesia or opioid-related adverse effects due to the biphasic pattern of postoperative pain. Therefore, we investigated the postoperative analgesic efficacy of PCA using an optimizing background infusion mode (OBIM) where the background injection rate varies depending on the patient’s bolus demand. Materials and Methods: We prospectively enrolled 204 patients who underwent laparoscopic cholecystectomy in a randomized, controlled, double-blind study. Patients were allocated to either the optimizing (group OBIM) or the traditional background infusion group (group TBIM). The numeric rating scale (NRS) score for pain was evaluated at admission to and discharge from the recovery room, as well as at the 6th, 24th, and 48th postoperative hours. Data on bolus demand count, total infused volume, and background infusion rate were downloaded from the PCA device at 30-min intervals until the 48th postoperative hour. Results: The NRS score was not significantly different between groups throughout the postoperative period (p = 0.621), decreasing with time in both groups (p < 0.001). The bolus demand count was not significantly different between groups throughout (p = 0.756). The mean total cumulative infused PCA volume was lower in group OBIM (84.0 (95% confidence interval: 78.9−89.1) mL) than in group TBIM (102 (97.8−106.0) mL; p < 0.001). The total cumulative opioid dose in fentanyl equivalents, after converting sufentanil to fentanyl using an equipotential dose ratio, was lower in group OBIM (714.1 (647.4−780.9) μg) than in group TBIM (963.7 (870.5−1056.9) μg); p < 0.001). The background infusion rate was significantly different between groups throughout the study period (p < 0.001); it was higher in group OBIM than in group TBIM before the 12th postoperative hour and lower from the 18th to the 48th postoperative hour. Conclusions: The OBIM combined with bolus dosing reduces the cumulative PCA volume and opioid consumption compared to the TBIM combined with bolus dosing, while yielding comparable postoperative analgesia and bolus demand in patients undergoing laparoscopic cholecystectomy.


2022 ◽  

Laparoscopic cholecystectomy is one of the most common surgical procedures. Even though there is less postoperative pain with laparoscopic cholecystectomy than with open cholecystectomy, severe pain can occur, particularly within the first 24 hours. Evaluation of the efficacy of ultrasound-guided interfascial plane blocks for postoperative analgesia of laparoscopic cholecystectomy has recently come to prominence. The aim of our study was to compare the postoperative analgesic efficacy of thoracoabdominal nerves block through perichondrial approach (TAPA) and modified-TAPA (m-TAPA) blocks in patients who underwent laparoscopic cholecystectomy. The present study included 56 patients who underwent laparoscopic cholecystectomy under general anesthesia and received TAPA or m-TAPA block for perioperative analgesia. Each patient signed a written informed consent form. Block times and numerical rating scale (NRS) scores 1, 2, 3, and 12 hours postoperatively, hourly and total tramadol amount of use via the patient-controlled analgesia device, and additional analgesic drug consumption were all recorded. The TAPA group had significantly longer block application times than the m-TAPA group. At 1 and 12 hours, NRS scores were lower in the TAPA group. However, the mean NRS scores, total tramadol use, and use of additional analgesics were comparable between the groups. TAPA and m-TAPA block methods reduced NRS scores by alleviating pain after laparoscopic cholecystectomy procedures, thereby reducing the need for additional analgesics. Block times for TAPA were significantly longer than those for m-TAPA. However, both block applications were completed in a short period, smoothly and safely. The analgesic effect of TAPA block was more distinctive at 1 and 12 hours, and NRS scores were lower. However, we think that both block methods, when used under ultrasound guidance, will provide effective analgesia by supplementing the multimodal analgesia planned for laparoscopic cholecystectomy and other abdominal operations.


2012 ◽  
Vol 78 (5) ◽  
pp. 574-581 ◽  
Author(s):  
Eric Haas ◽  
Erol Onel ◽  
Howard Miller ◽  
Madhu Ragupathi ◽  
Paul F. White

This randomized, active-controlled study evaluated the extent and duration of analgesia after administration of liposome bupivacaine (LB), a novel formulation of bupivacaine, compared with bupivacaine HCl given via local infiltration in excisional hemorrhoidectomy. One hundred patients were randomly assigned to receive a single dose of bupivacaine HCl 75 mg (0.25% with 1:200,000 epinephrine) or LB 66, 199, or 266 mg upon completion of hemorrhoidectomy. Postoperative pain intensity was assessed using a numeric rating scale at rest to calculate a cumulative pain score (area under the curve). Cumulative pain scores were significantly lower with LB at each study dose ( P < 0.05) compared with bupivacaine HCl 72 hours after surgery. Post hoc analysis showed that mean total postoperative opioid consumption was statistically significantly lower for the LB 266-mg group compared with the bupivacaine HCl group during the 12- to 72-hour postoperative period ( P = 0.019). Median time to first opioid use was 19 hours for LB 266 mg versus 8 hours for bupivacaine HCl ( P = 0.005). Incidence of opioid-related adverse events was 4 per cent for LB 266 mg compared with 35 per cent for bupivacaine HCl ( P = 0.007). Local infiltration with LB resulted in significantly reduced postsurgical pain compared with bupivacaine HCl in patients after hemorrhoidectomy surgery.


2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Young Suk Kwon ◽  
Ji Su Jang ◽  
Na Rea Lee ◽  
Seong Su Kim ◽  
Young Ki Kim ◽  
...  

Background. Oxycodone, a semisynthetic opioid, has been widely used for acute and chronic pain.Objectives. The aim of this study was to compare the analgesic and adverse effects of oxycodone and alfentanil on postoperative pain after laparoscopic cholecystectomy.Methods. This was a prospective, randomized, double-blind study. A total of 82 patients undergoing laparoscopic cholecystectomy were randomly assigned to receive either oxycodone or alfentanil using intravenous patient-controlled analgesia (PCA). PCA was administered as a time-scheduled decremental continuous infusion based on lean body mass for 48 hours postoperatively. Patients were assessed for pain with a visual analogue scale (VAS), the cumulative PCA dose, adverse effects, sedation level at 1, 4, 8, 16, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours.Results. There were no significant differences (p<0.05) between the two groups in VAS score, cumulative PCA dose, adverse effects, sedation level at 1, 4, 8, 16, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours.Conclusions. Our data showed that the analgesic and adverse effects of oxycodone and alfentanil were similar. Therefore, oxycodone may be a good alternative to alfentanil for pain management using intravenous PCA after laparoscopic cholecystectomy when used at a conversion ratio of 10 : 1. This trial is registered withKCT0001962.


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