Clinical Research Directory

Effect of Bilateral SPG and Infraorbital Nerve Blocks on Recovery After Septorhinoplasty

This prospective, randomized, double-blind controlled study aims to compare the effects of bilateral sphenopalatine ganglion and infraorbital nerve blocks on postoperative recovery quality in patients undergoing elective septorhinoplasty under general anesthesia. A total of 90 adult patients (aged 18-65, ASA I-II) will be randomly assigned into two groups: Group 1 will receive bilateral sphenopalatine ganglion block, and Group 2 will receive bilateral infraorbital nerve block. Both blocks will be performed using 4 mL of 0.5% bupivacaine. The primary outcome is the quality of recovery assessed 24 hours after surgery using the QoR-15 questionnaire. Secondary outcomes include intraoperative anesthetic consumption (propofol, remifentanil), emergence agitation (RASS scale), postoperative pain (VAS), need for rescue analgesics (morphine), postoperative nausea and vomiting (VDS), antiemetic consumption (ondansetron), facial edema and hematoma, and length of stay in the post-anesthesia care unit (PACU). All procedures will follow standardized general anesthesia protocols. The study aims to determine which block technique provides superior postoperative recovery, better pain control, fewer side effects, and higher patient satisfaction. No placebo will be used, and no biological samples will be collected.

PeRiOperative Medicine Platform Trial

Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.

MAG-PAIN - MAGnesium for Postoperative Analgesia In the Newly Delivered

The study aims to investigate whether a commonly used medicine, magnesium, can help reduce pain after a Caesarean section. A total of 150 participants will be included. Their usual medical care will not change, and participation is entirely voluntary. The purpose of the study is to determine whether magnesium can improve pain relief after surgery and support faster recovery and bonding with the newborn. Before the operation, potential participants will receive a text message containing a short questionnaire about their background and their expectations regarding postoperative pain. On the day of surgery, all patients will receive two intravenous lines as part of routine care. Those who participate in the study will be asked to rate how painful this insertion was on a scale from one to ten. The participants will then be randomly assigned to receive either magnesium or a saltwater solution through a 100 ml drip, which is administered after the baby is born. Neither participants nor the clinical staff will know which solution has been given, and no blood samples will be collected. After the procedure, participants will be asked several times about their pain level. During the first three days after the operation, each participant will receive one text message per day with a short questionnaire about their pain, general recovery, and early bonding with their newborn. Fourteen days after the operation, and again three months later, they will receive additional questionnaires similar to the earlier ones. Each questionnaire takes approximately five to seven minutes to complete, and no extra hospital visits are required. Magnesium can cause side effects, but the risks associated with the dose used in the study are low. The most common side effect is a brief burning sensation at the infusion site, which is not harmful. Magnesium is widely used in medical care, including in pregnant patients, and the study team considers the treatment safe. Because the medication is administered after birth, it does not affect the baby and does not increase risks during breastfeeding. All collected information will be handled securely and confidentially. Data will be coded so that individual participants cannot be directly identified, and only the research team will have access to the key linking codes to individuals. Participants have the right to access their data, request corrections, ask for deletion of their information, or limit how their data is used. The study has been approved by the Swedish Ethical Review Authority, and results will be published in a scientific journal without identifying any participant. No financial compensation is provided, but participants are covered by the usual patient and medication insurance. To ensure that the study is conducted correctly, authorized monitors or authorities may compare study data with medical records. These individuals must sign confidentiality agreements. By giving consent to participate, individuals allow this review. All data will be stored according to legal archiving requirements. Participation in the study is completely voluntary. Individuals may withdraw at any time, and if they do, their collected data will be deleted. Their medical care before, during, and after the operation will not be affected by their decision to participate or withdraw.

Effect of Preoperative Erector Spinae Plane Block on Recovery Quality, Time to Return to Daily Activities, and Postoperative Pain Scores in Inguinal Hernia Surgery

This study aims to evaluate the effect of the erector spinae plane block (ESPB), performed after surgery, on quality of recovery, postoperative pain, and time to return to daily activities in patients undergoing open inguinal hernia repair under spinal anesthesia. Postoperative pain following inguinal hernia surgery may delay recovery and negatively affect patients' return to normal daily life. Although ESPB has been widely used as an effective analgesic technique in various surgical procedures, its effectiveness in inguinal hernia repair remains limited and not well established. In this randomized controlled study, patients will be divided into two groups: one group will receive ESPB after surgery, while the control group will not receive any block. All patients will receive standard postoperative analgesia. Quality of recovery, acute pain scores, and analgesic consumption will be assessed within the first 24 hours after surgery, and return to daily activities will be evaluated 30 days after surgery. The primary outcome of this study is quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery. Scores will be recorded preoperatively and 24 hours after surgery. Secondary outcomes include postoperative pain intensity, total opioid consumption, and time to return to daily activities. Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, at 15, 30, 60, and 120 minutes, as well as 6, 12, and 24 hours after surgery. Total opioid consumption will be determined by recording the cumulative dose of intravenous tramadol administered as rescue analgesia within the first 24 hours after surgery. Time to return to daily activities will be evaluated via telephone follow-up 30 days after surgery.

Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery

Most minor perianal surgeries are performed as day-case procedures requiring rapid recovery and effective symptom control. Saddle block anesthesia (SBA) provides reliable perineal anesthesia with minimal hemodynamic and motor effects, promoting faster recovery than general anesthesia. However, the duration of sitting after intrathecal injection influences anesthetic spread, and the optimal sitting time to balance adequate anesthesia with early discharge remains unclear.

Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population. The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.

Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa

This observational study aims to evaluate the validity, reliability and feasibility of the Setswana-translated version of the 15-item Quality of Recovery (QoR-15) questionnaire. The question it aims to answer is: Does the Setswana translation of the QoR-15 serve as a valid, reliable and user friendly tool for assessing postoperative recovery in Setswana speaking patients undergoing orthopaedic surgery at a tertiary hospital in Gauteng, South Africa? The participants will be asked to complete the Setswana-translated QoR-15 questionnaire both preoperatively and postoperatively. In addition, they will be asked to rate their overall postoperative recovery using a visual analog scale (VAS).

Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy

The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by: Primary Objective: Primary outcome measure: ● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours Secondary outcome measure: * Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge * Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow. * Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours * Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU) Hypothesis: The investigators hypothesize that the application of ITPB targeting the retro-SCTL space in patients undergoing open hepatectomy will improve overall quality of recovery and pain score.

Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital

Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery. Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.