Evaluation of preoperative duloxetine use for postoperative analgesia following laparoscopic cholecystectomy: A randomized controlled trial

Abstract

Background: The pain pattern after laparoscopic cholecystectomy (LC) is complex and distinct from postoperative pain after other laparoscopic procedures, suggesting that procedure-specific optimal analgesic management plans should be proposed. Duloxetine, a non-opioid neuromodulator, has been widely used to manage pain with dual central and peripheral analgesic properties.Aims: To assess the effect of preoperative administration of duloxetine compared to placebo on postoperative pain control in patients undergoing LC.Patients and Methods: This study was a randomized, parallel-group, placebo-controlled, double-blinded study performed on patients undergoing LC. Patients were randomly divided into two groups of 30 each on the day of surgery in the preoperative holding area, using a computer-generated random number to receive 60 mg duloxetine as a single oral dose 2 h before the procedure or placebo. The primary outcome was the difference in the mean of visual analogue scale (VAS) scores between the two studied groups, as measured by the area under the curve (AUC) of the VAS scores.Results: The derived AUC of VAS scores in the duloxetine group (757.89 ± 326.01 mm × h) was significantly lower than that calculated for the control group (1005.1 ± 432.5 mm × h). The mean postoperative VAS scores recorded at 4 and 24 h were statistically different between the study groups (p = 0.041 and 0.003, respectively). As observed in the survival curve analysis, there was no significant difference (p = 0.665) for the time until the patient’s first request for rescue medications in the two groups. The frequency of postoperative nausea and vomiting (PONV) was lower in patients of the duloxetine group than that recorded in those allocated to the control group at 8 and 24-h time intervals (p = 0.734 and 0.572, respectively).Conclusion: Preoperative use of duloxetine reduces postoperative pain significantly compared with placebo. In addition, its use is associated with a reduction in PONV. These preliminary findings suggest that duloxetine could play a role in the acute preoperative period for patients undergoing LC.Clinical Trial Registration: [https://clinicaltrials.gov/ct2/show/NCT05115123, identifier NCT05115123],

Postoperative acute pain management with duloxetine as compared to placebo: A systematic review with meta‐analysis of randomized clinical trials

“…Details of the included studies are shown in the table of characteristics of eligible studies (Table 1). Patients of the enrolled trial underwent knee arthroplasty, 20,25,47,48 spinal surgeries, 21,26–28,33,37,46 modified radical mastectomies, 22,24,35 abdominal hysterectomies, 23,32,36,40 laparoscopic gynecological surgery and cholecystectomy, 29,31,34,41,43,44 hip surgery, 30,39 shoulder surgery, 46 open colectomies, 42 and abdominal cancer surgery 38 …”

“…The dose of duloxetine administered as an intervention was 60 mg in included studies. Duloxetine or placebo was given for 1 day just before the operation, 29,32,34–36,38,40,41,43,44 for two consecutive days around the day of surgery, 20,23,26–28,31,37,42,45 for 5–7 days, 24,30,33,46 for 2 weeks, 22,25,39,47,48 and 2 weeks before to 2 weeks after surgery 21…”

“…The primary outcome of the included study is pain scores at different timelines, 24,25,28,32,36,39–41,43,44,46,48 total rescue analgesia requirements at different timelines, 20–22,26,27,29,33,35,38,42,43,46,47 Quality of recovery score QoR‐40, 23,31 cognitive functions, 28 duration of spinal anesthesia 30 and time to first rescue analgesia 32,37,45 …”

“…Pain assessment in studies was done with pain scores at different timelines at rest and movement, 20–30,33–41,48 time to first rescue analgesia, 21,26,28,29,32–35,37,38,41 and total Rescue analgesia consumed. Rescue analgesia in different studies was morphine, 20,22,23,26,30,31,35,38,39,42,48 pethidine, 21,29,36 fentanyl, 27 paracetamol, 21,31,34,41,43–45,47 diclofenac sodium, 43 oral celecoxib 46–48 and tramadol 40,44–46 …”

Efficacy and safety of an extended-release sebacoyl dinalbuphine ester for laparoscopic cholecystectomy: A randomized controlled trial

“…[15] Areas under the curve (AUC) of the VAS were calculated by plotting the individual VAS score as curves in which the x-axis represented measurement time points from baseline (4-hours intervals) to 48 hours after surgery, and the y-axis represented the VAS score. [16] The secondary endpoints included total doses of rescue parenteral analgesics administered during hospital stay period, length of stay after operation, incidence of CPSP and patient's quality of life (QoL). CPSP was defined as the newly developed pain at the surgical site or incisional wounds within 3 months after surgery, as other etiologies of pain were excluded.…”