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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine hydrochloride | Active Comparator |
| |
| Liposomal bupivacaine plus bupivacaine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively | The postoperative period 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 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. | Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30608444 | Background | Korkmaz Toker M, Altiparmak B, Uysal AI, Demirbilek SG. The analgesic efficacy of oblique subcostal transversus abdominis plane block after laparoscopic hysterectomy: A randomized, controlled, observer-blinded study. Medicine (Baltimore). 2019 Jan;98(1):e13994. doi: 10.1097/MD.0000000000013994. | |
| 25790044 | Background |
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Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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| Liposomal bupivacaine plus bupivacaine | Drug | 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. |
|
| Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 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. | Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively. |
| Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months 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. | Postoperative day 7, month 1, and month 3. |
| Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months 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. | Postoperative day 7, month 1, and month 3. |
| 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. |
| Patient Satisfaction Scale，PSS | Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied." | Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3. |
| Ramsay Sedation Scale，RSS | 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. | Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours. |
| Quality of Recovery-40，QoR-40 | 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). | Postoperative hours 24, 48, and 72. |
| The duration of stay in the post-anesthesia care unit（PACU） | 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. | 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. |
| 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. |
| Adverse events，AEs | Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl. | Within 72 hours postoperatively. |
| Hutchins J, Vogel RI, Ghebre R, McNally A, Downs LS Jr, Gryzmala E, Geller MA. Ultrasound-guided subcostal transversus abdominis plane infiltration with liposomal bupivacaine for patients undergoing robotic-assisted hysterectomy: a retrospective study. Int J Gynecol Cancer. 2015 Jun;25(5):937-41. doi: 10.1097/IGC.0000000000000429. |
| 35817618 | Background | McDonald V, Wang Y, Patel A, Betcher R, Fontenot AC, Scoggin S, Black D. Laparoscopic guided liposomal bupivacaine injection compared to transversus abdominus plane block for postoperative pain after robotic gynecologic oncology surgery. Gynecol Oncol. 2022 Sep;166(3):432-437. doi: 10.1016/j.ygyno.2022.06.006. Epub 2022 Jul 9. |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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