Gynecologic Oncology Patient, Laparoscopic Surgery, Liposomal Bupivacaine, Transversus Abdominis Plane Block
Conditions
Brief summary
Laparoscopic surgery, characterized by minimal invasiveness, rapid recovery, and shorter hospital stays, has been widely adopted in Gynecologic Oncology. However, the elevation and stretching of the diaphragm following pneumoperitoneum, combined with increased intra-abdominal pressure compressing visceral organs and causing ischemia-hypoxia, can trigger systemic inflammatory responses and lead to postoperLaparoscopic surgery, characterized by minimal invasiveness, rapid recovery, and shorter hospital stays, has been widely adopted in gynecological procedures. However, the elevation and stretching of the diaphragm following pneumoperitoneum, combined with increased intra-abdominal pressure compressing visceral organs and causing ischemia-hypoxia, can trigger systemic inflammatory responses and lead to postoperative pain. Inadequate or delayed pain management may prolong hospitalization, and some patients may develop chronic pain, resulting in altered behavioral patterns. As one of the analgesic strategies after abdominal surgery, transversus abdominis plane block (TAPB) not only reduces opioid consumption and the incidence of complications but also avoids adverse effects associated with epidural analgesia. Nevertheless, the analgesic duration provided by a single-injection TAPB is limited, while continuous TAPB faces constraints in clinical application due to challenges such as catheter fixation.Inadequate or delayed pain management may prolong hospitalization, and some patients may develop chronic pain, resulting in altered behavioral patterns. As one of the analgesic strategies after abdominal surgery, TAPB not only reduces opioid consumption and the incidence of complications but also avoids adverse effects associated with epidural analgesia. Nevertheless, the analgesic duration provided by a single-injection TAPB is limited, while continuous TAPB faces constraints in clinical application due to challenges such as catheter fixation. Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours.However, its efficacy and safety in laparoscopic surgery not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of Ultrasound-guided TAPB utilizing liposomal bupivacaine plus bupivacaine for postoperative pain management in patients undergoing Laparoscopic Surgery in Gynecologic Oncology.
Interventions
DRUGBupivacaine hydrochloride
Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, with 20 mL of 0.25% bupivacaine administered per side. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, 20 mL (266 mg) of liposomal bupivacaine will be mixed with 20 mL of 0.25% bupivacaine hydrochloride (50 mg, diluted in normal saline) to prepare a 40 mL solution. A volume of 20 mL will be administered to each side.The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for elective Laparoscopic Surgery in Gynecologic Oncology under general anesthesia; 2. Ages 18 to 64 years old； 3. American Society of Anesthesiologists (ASA) physical status of I-III； 4. Glasgow Coma Scale (GCS) score of 15； 5. Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
Exclusion criteria
1. History of chronic pain syndrome of any cause. 2. Patients with heart conduction block (sinus block or atrioventricular block). 3. Patients with unstable coronary artery disease. 4. Patients with gastric ulcer or gastric bleeding. 5. Patients with diabetes and are being treated with insulin. 6. Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran. 7. Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN. 8. Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery. 9. Patients with a history of diagnosed mental illness or currently taking psychotropic medication. 10. Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery. 11. Pregnancy or breastfeeding. 12. Extreme body mass index (BMI) (\< 15 or \> 35). 13. Participation in another interventional trial that interferes with the intervention or outcome of this trial. 14. Patients with a history of allergy to local anaesthetics or one of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively | The postoperative period 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively | Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively. | The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain. |
| Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively | Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively. | The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain. |
| Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively | Postoperative day 7, month 1, and month 3. | The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain. |
| Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively | Postoperative day 7, month 1, and month 3. | The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain. |
| Time to request of first analgesia | Within 48 hours postoperatively. | — |
| Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses | Postoperative Hours 4, 8, 24, and 48. | — |
| Duration days of Oral Oxycodone and Acetaminophen Tablets Administration | Within 3 months postoperatively. | — |
| Total dosage of orally oxycodone and acetaminophen tablets | Within 3 months postoperatively. | — |
| Intraoperative Anesthetic Dosage | During the surgical anesthesia phase. | — |
| Ramsay Sedation Scale，RSS | Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours. | The RSS utilizes a six-point scale to evaluate sedation levels. The total score ranges from 1 to 6 as follows: anxious or agitated (1 point); oriented, calm, and cooperative (2 points); responsive to commands (3 points); drowsy with brisk response to glabellar tap or loud auditory stimulus (4 points); drowsy with sluggish response to glabellar tap or loud auditory stimulus (5 points)；and drowsy with no response whatsoever（6）points. A score of 1 reflects inadequate sedation, scores of 2 to 4 indicate satisfactory sedation, while scores of 5 to 6 denote oversedation. |
| Quality of Recovery-40，QoR-40 | Postoperative hours 24, 48, and 72. | The Quality of Recovery-40 (QoR-40) serves as a globally recognized metric for evaluating the quality of recovery. It encompasses five dimensions-emotional state, physical comfort, physiological independence, psychological support, and pain-comprising a total of 40 items, each rated on a 1-5 scoring scale. The overall QoR-40 score ranges from 40 (indicating extremely poor recovery quality) to 200 (representing excellent recovery quality). |
| The duration of stay in the post-anesthesia care unit（PACU） | The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute. | The time from the end of surgery until the patient regains consciousness and has stable vital signs after extubating and is subsequently transferred back to the ward. |
| Length of Stay (LOS) | Perioperation. | — |
| Total hospitalization expenses incurred during the patient's inpatient stay | Perioperation. | — |
| Postoperative nausea and vomiting，PONV | Postoperatively within 72 hours. | — |
| Patient Satisfaction Scale，PSS | Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3. | Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied." |
| Adverse events，AEs | Within 72 hours postoperatively. | Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl. |
Countries
China
Contacts
CONTACTFang Luo
Outcome results
None listed