Application of opioid-free general anesthesia for gynecological laparoscopic surgery under ERAS protocol: a non-inferiority randomized controlled trial

Abstract

Background Enhanced recovery after surgery (ERAS) is now widely used in various surgical fields including gynecological laparoscopic surgery, but the advantages of opioid-free anesthesia (OFA) in gynecological laparoscopic surgery under ERAS protocol are inexact. Aims This study aims to assess the effectiveness and feasibility of OFA technique versus traditional opioid-based anesthesia (OA) technique in gynecological laparoscopic surgery under ERAS. Methods Adult female patients aged 18 ~ 65 years old undergoing gynecological laparoscopic surgery were randomly divided into OFA group (Group OFA, n = 39) with esketamine and dexmedetomidine or OA group (Group OA, n = 38) with sufentanil and remifentanil. All patients adopted ERAS protocol. The primary outcome was the area under the curve (AUC) of Visual Analogue Scale (VAS) scores (AUCVAS) postoperatively. Secondary outcomes included intraoperative hemodynamic variables, awakening and orientation recovery times, number of postoperative rescue analgesia required, incidence of postoperative nausea and vomiting (PONV) and Pittsburgh Sleep Quality Index (PSQI) perioperatively. Results AUCVAS was (Group OFA, 16.72 ± 2.50) vs (Group OA, 15.99 ± 2.72) (p = 0.223). No difference was found in the number of rescue analgesia required (p = 0.352). There were no between-group differences in mean arterial pressure (MAP) and heart rate (HR) (p = 0.211 and 0.659, respectively) except MAP at time of surgical incision immediately [(Group OFA, 84.38 ± 11.08) vs. (Group OA, 79.00 ± 8.92), p = 0.022]. Times of awakening and orientation recovery in group OFA (14.54 ± 4.22 and 20.69 ± 4.92, respectively) were both longer than which in group OA (12.63 ± 3.59 and 18.45 ± 4.08, respectively) (p = 0.036 and 0.033, respectively). The incidence of PONV in group OFA (10.1%) was lower than that in group OA (28.9%) significantly (p = 0.027). The postoperative PSQI was lower than the preoperative one in group OFA (p = 0.013). Conclusion In gynecological laparoscopic surgery under ERAS protocol, OFA technique is non-inferior to OA technique in analgesic effect and intraoperative anesthesia stability. Although awakening and orientation recovery times were prolonged compared to OA, OFA had lower incidence of PONV and improved postoperative sleep quality. Trial registration ChiCTR2100052761, 05/11/2021.

The Performance of Opioid-Free Anesthesia for Bariatric Surgery in Clinical Practice

“…We planned to observe 50 patients in the OFA group and 50 patients in the OBA group. The number of cases was determined to allow for examining a larger patient collective than had previously been done in smaller randomized studies [2][3][4][5][6]. Normal distribution for continuous data was tested using the Kolmogorov-Smirnov test.…”

“…We observed that 9 (18%) patients in the OBA cohort did not require piritramide. Postoperative opioid consumption (Piritramide) was lower in the OFA group (OFA: 0 [0-3.4], OBA: 6 [3][4][5][6][7][8][9]; P ≤ 0,001). 26 (52%) of 50 patients in the OFA group and 38 (77.6%) of 49 patients in the OBA group received droperidol in the PACU (chi-square test, P = 0.008).…”

“…The use of OFA has been investigated for various types of surgery (e.g. gynecologic surgery [4,6], bariatric surgery [1], cardiac surgery [7], urological surgery [8], orthopedic surgery [9]), and has been demonstrated to reduce postoperative pain [1,10,11] and postoperative nausea and vomiting (PONV) [6,10,11]. There is also evidence that OFA improves postoperative recovery [1,4,12].…”

Surgeons’ knowledge regarding perioperative pain management in patients with opioid use disorder: a survey among 260 members of the American College of Surgeons

“…As research efforts continue to focus on how best to treat patients’ perioperative pain, including those with OUD, the concept of “opiate free anesthesia” (OFA) is emerging as a method to decrease the use of opioids [ 29 ]. By using a multimodal nonopioid approach to anesthesia and perioperative analgesia, patients are able to avoid opioids altogether with either similar or improved outcomes compared to standard opioid analgesia [ 30 – 32 ]. A meta-analysis by D’Amico and colleagues examined the use of OFA in thoracic surgery and concluded that it was associated with lower rates of complications, lower pain scales and lower morphine consumption postoperatively [ 33 ].…”

Safety and Effectiveness of Multimodal Opioid-Free Anesthesia for Pain and Recovery after Laparoscopic Surgery: A Systematic Review and Meta- Analysis

“…The studies were conducted in eight different countries, including one in Turkey, one in Belgium, three in Egypt, two in China, one in Germany, one in South Korea, one in Macedonia, one in Vietnam, and one in Cameroon. All studies were performed on patients undergoing laparoscopic surgery; ve studies were on gynecologic laparoscopic surgery [25][26][27][28][29], three studies were on laparoscopic cholecystectomy [30][31][32], three studies were on laparoscopic bariatric surgery [33][34][35], and one study was on laparoscopic radical colon surgery [36]. All studies were randomized controlled trials and the intervention studied was OFA, a detailed description of the anesthetic drugs used is given in Table 1.…”