The Intrathecal Morphine for Percutaneous Endoscopic Lumbar Discectomy (IMPELD) Study: Rationale and Protocol for a Double-blinded Randomized Placebo-controlled Trial

BackgroundPercutaneous endoscopic lumbar discectomy (PELD), a minimally invasive spinal technique for lumbar disc herniation (LDH), has gained popularity globally and yielded satisfying results. However, PELD is often performed on awaking patients to avoid nerve injury, thus the intraoperative analgesia of PELD is sometimes insufficient. The effect of intrathecal morphine (ITM) has been well proved in various surgical specialties, and this study aims to investigate the effectiveness and safety of ITM on PELD.MethodsThe intrathecal morphine for percutaneous endoscopic lumbar discectomy (IMPELD) trial is a double-blind, randomized, placebo-controlled trial. The 90 eligible LDH patients undergoing PELD will be randomly assigned to receive either ITM or placebo during spinal anesthesia, at a 1:1 ratio, with a one-month follow-up period. Average intraoperative pain intensity will be the primary outcome. Secondary outcome measures include intraoperative pain intensity assessed at each 30 min intraoperatively, postoperative pain intensity, perioperative analgesia requirements, functional evaluation, radiographic characteristics, overall satisfaction, other characteristics and adverse events.DiscussionCurrently, there is a lack of scientific evidence to provide a reliable method to reduce intraoperative pain of PELD. The IMPELD trial was designed to provide evidence regarding whether 100 ug of ITM is an effective and safe coanalgesic approach for PELD procedure.Trial registrationThe trial was registered with the Chinese Clinical Trial Registry (identifier ChiCTR2000039842). Registered on November 11th, 2020.

Non-Toxic Anesthesia for Cataract Surgery

Background: To study the safety and efficacy provided by a minimal and localized anesthesia in cataract surgery. Methods: Randomized controlled trial. A total of 100 patients undergoing cataract surgery were randomly divided into two groups of 50, which respecitvely received conventional topical anesthesia consisting of preservative-free Oxibuprocaine hydrochloride 0.4% drops or minimal localized anesthesia, administered with a cotton bud soaked in preservative-free Oxibuprocaine hydrochloride 0.4% applied to clear cornea on the access sites for 10 s immediately before surgery. The mean outcome measures were intraoperative pain and the incidence of postoperative ocular discomfort. Results: All patients tolerated well the procedure, giving patin scores between 1–3. Fifteen patients (30%) of group 1 and ten of group 2 (25%) required supplemental anesthesia. No intraoperative complications were recorded. No eyes had epithelial defects at the end of the surgery or at postoperative check-ups. Conclusions: Minimal anesthesia in cataract surgery resulted quick, safe and non-invasive.

Opioid-free anesthesia compared to opioid anesthesia for lung cancer patients undergoing video-assisted thoracoscopic surgery: A randomized controlled study

Background Reducing intra-operative opioid consumption benefits patients by decreasing postoperative opioid-related adverse events. We assessed whether opioid-free anesthesia would provide effective analgesia-antinociception monitored by analgesia index in video-assisted thoracoscopic surgery. Methods Patients (ASA Ⅰ-Ⅱ, 18–65 years old, BMI <30 kg m−2) scheduled to undergo video-assisted thoracoscopic surgery under general anesthesia were randomly allocated into two groups to receive opioid-free anesthesia (group OFA) with dexmedetomidine, sevoflurane plus thoracic paravertebral blockade or opioid-based anesthesia (group OA) with remifentanil, sevoflurane, and thoracic paravertebral blockade. The primary outcome variable was pain intensity during the operation, assessed by the depth of analgesia using the pain threshold index with the multifunction combination monitor HXD‑I. Secondary outcomes included depth of sedation monitoring by wavelet index and blood glucose concentration achieved from blood gas. Results One hundred patients were randomized; 3 patients were excluded due to discontinued intervention and 97 included in the final analysis. Intraoperative pain threshold index readings were not significantly different between group OFA and group OA from arriving operation room to extubation (P = 0.86), while the brain wavelet index readings in group OFA were notably lower than those in group OA from before general anesthesia induction to recovery of double lungs ventilation (P <0.001). After beginning of operation, the blood glucose levels in group OFA increased compared with baseline blood glucose values (P < 0.001). The recovery time and extubation time in group OFA were significantly longer than those in group OA (P <0.007). Conclusions This study suggested that our OFA regimen achieved equally effective intraoperative pain threshold index compared to OA in video-assisted thoracoscopic surgery. Depth of sedation was significantly deeper and blood glucose levels were higher with OFA. Study’s limitations and strict inclusion criteria may limit the external validity of the study, suggesting the need of further randomized trials on the topic. Trial registration: ChiCTR1800019479, Title: "Opioid-free anesthesia in video-assisted thoracoscopic surgery lobectomy".

Efficacy of a combination of regional methods of anesthesia with general anesthesia in corneal transplantation

Background. Despite the significant development of modern anesthesiology, the pain relief of surgical patients is still unsatisfactory. Inadequate pain management causes psychological discomfort and complications. The combination of general anesthesia with various options for local anesthesia allows one to get closer to solving the problem of pain. The aim of the study was to compare the effect of multicomponent balanced anesthesia (intravenous + inhalation) and multicomponent balanced anesthesia, supplemented by pterygopalatine fossa blockade on the safety and efficacy of anesthesia for corneal transplantation. Materials and methods. The study included 73 patients, divided into two groups. Group С received multicomponent balanced anesthesia, group B — pterygopalatine fossa blockade additionally. The main criteria for evaluating the results of the study were: stability of hemodynamics and gas exchange during surgery, the severity of intraoperative pain syndrome by recording the analgesia nociception index, the severity of postoperative pain syndrome and the incidence of postoperative nausea and vomiting. Results. Both schemes of anesthetic management made it possible to avoid pronounced fluctuations in hemodynamic and gas exchange parameters at all stages of the study. Analyzing the severity of intraoperative pain, we found that in group С, pain relief could be considered insufficient during the first 7 minutes of the most traumatic stage of the operation, while in group B the analgesia nociception index did not decrease below 50. Statistically significant differences were obtained during 8 out of 10 minutes of the stage. Analysis of the pain relief quality in the postoperative period has shown that the level of pain according to the visual analogue scale upon awakening was equal to 0 in both groups, at the next three stages of the study (two and six hours after surgery and on the morning of the next day) the level pain in group C was significantly higher than in group B. Conclusions. The addition of regional blockade to multicomponent general anesthesia allows for adequate control of postoperative pain without compromising the safety profile.

A Comparison between Intrathecal Nalbuphine and Fentanyl for Intraoperative Pain Management during Uterine Exteriorization in Cesarean Section: A Randomized Controlled Trial

BACKGROUND: Uterine exteriorization during cesarean section is linked to an increased incidence of visceral pain. AIM: This study explored the ability of intrathecal nalbuphine to alleviate this accompanied pain to be used as an effective safer alternative to fentanyl, as there is almost no study compared between these agents to alleviate visceral pain induced by uterine exteriorization. METHODS: This double-blinded randomized controlled research was done on 135 cases subjected to cesarean section with exteriorization of the uterus. Patients were randomized equally into F, N, and C groups which received 25 μg fentanyl, 800 μg nalbuphine, and 0.5 ml saline, respectively, added to intrathecal 0.5% hyperbaric bupivacaine. The occurrence of visceral and shoulder pain and their VAS, the need for rescue IV fentanyl, adverse events, hemodynamics, and Apgar scores were evaluated. RESULTS: The incidence of visceral pain was 22.2%, 24.4%, and 66.7% for Groups F, N, and C, respectively. Patients who needed rescue IV fentanyl were 6.7%, 11.1%, and 60% for Groups F, N, and C, respectively. The statistical difference regarding these parameters was highly significant (p < 0.0001) between C group and both F and N groups but insignificant between F and N groups. Nausea, shivering, itching, and bradycardia were significantly lower (p < 0.05) in N group in comparison to F and C. HR had a significant difference between F group and both N and C groups. CONCLUSION: Intrathecal nalbuphine is an effective safer alternative to fentanyl to control visceral pain induced by uterine exteriorization during cesarean delivery.

The Effectiveness of Intraoperative Ketamine and Fentanyl as Preemptive Analgesia Assessed with qNOX Score

Background: Inadequate management of intraoperative pain poses a risk of postoperative chronic pain complications. The use of preemptive analgesia before the onset of surgical incision stimulation was considered to prevent central sensitization. Clinical research around the terms of preemptive analgesia needs to be proven by nociception-based intraoperative monitoring. An objective modality with EEG guidance can provide information on noxious stimuli.Objective: To determine the effectiveness of ketamine and fentanyl administration as preemptive analgesia measured by qNOX scores through the CONOX tool.Methods: This study is a single-blinded randomized experiment with the division of two groups: control and treatment. The control group received preemptive fentanyl, and the treatment group received preemptive ketamine and fentanyl. Then the qNOX score was assessed during operation.Result: The qNOX score of the treatment group in minute-15 and 30 was lower than the control group (p = 0.007; p = 0.025), while in the minute-90 it was higher than the control group (p = 0.001). The mean first 1-hour qNOX score was lower in the treatment group (p <0.001), while in the second 1-hour was higher in the treatment group (p = 0.003). The mean total dose of fentanyl supplementation in the treatment group was lower than in the control group (71.3 ± 25.1 grams vs. 92.0 ± 28.3 grams; p = 0.044).Conclusion: The administration of combined ketamine and fentanyl as preemptive analgesia is more effective in the first hour of surgery compared to single preemptive fentanyl measured by qNOX score. Preemptive ketamine and fentanyl decrease the total dose of intraoperative fentanyl supplementation compared with single-dose preemptive fentanyl administration.