Clinical trial NCT05450055: Intraperitoneal Lidocaine in Ovarian Cancer Surgery
Official title: A Randomized Controlled Trial to Investigate Effect of Postoperative Intraperitoneal Lidocaine on the Analgesic and Prognosis of Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Post Operative Pain
Keywords: Postoperative intraperitoneal lidocaine
Intraperitoneal analgesic
Ovarian cancer
Prognosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty patients were expected to participate in a centralized randomized study method divided into two groups of 30 patients per group: the intraperitoneal analgesic group and the normal saline control group.
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to improve the postoperative analgesia effect and prognosis of patients with ovarian cancer after laparotomy surgery. This is a randomized, double-blind, controlled trial to evaluate analgesia and patient outcomes after local peritoneal anesthesia after surgery.

Detailed description: This is a prospective, randomized, controlled clinical study. Sixty patients were expected to participate in a centralized randomized study method divided into two groups of 30 patients per group: the intraperitoneal analgesic group and the normal saline control group. Standard routine anesthesia was performed in both groups using the same method, and intravenous analgesia pump was routinely used in clinical use after surgery. The intraperitoneal analgesic group was continuously pumped with local anesthetics into the abdominal cavity, while the control group was pumped with normal saline. Visual analogue pain score (VAS), amount of remedial analgesia and use of analgesia pump were recorded at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours after operation. Record the time when the patient began drinking and eating, and the time when gastrointestinal function (defecation or exhaust) recovered. The time of starting to walk on the ground (including the time of needing attendant assistance or not) and the time of meeting the standard of postoperative discharge preparation. Perioperative peripheral blood samples were collected for five times (T0 before anesthesia induction, T1 after tracheal extubation, T2 on the morning of the first postoperative day, T3 on the morning of the second postoperative day, and T4 on the morning of the third postoperative day), and inflammatory factors and tumor-related indicators were monitored. Adverse reactions were recorded. The prognosis of the patients was followed up 5 years after operation.

Eligibility criteria: Inclusion Criteria:

* The American Society of Anesthesiologists (ASA) rated them as grade I to II, aged 18 to 75 years.
* Patients undergoing elective laparotomy for ovarian cancer reduction (surgical resection includes the whole uterus with or without double adnexa, lymph node biopsy, dissection, appendectomy, etc.).

Exclusion Criteria:

* Suffering from mental illness or unable to cooperate with pain and related index scoring, unable to use automatic pump.
* Peritoneal infection existed before surgery
* Past history of arrhythmia
* Severe liver and kidney dysfunction existed before surgery
* Known allergy to local anesthetics
* Do not agree to participate in the research

Primary outcomes:
measure: Postoperative analgesic use
timeFrame: Postoperative 72 hours
Secondary outcomes:
measure: Survival time (months)
timeFrame: Postoperative 5 years
measure: Disease free survival time (months)
timeFrame: Postoperative 5 years
measure: Recurrence (yes/no, if yes ,record recurrence date)
timeFrame: Postoperative 5 years
measure: Postoperitive chronic pain duration (months)
timeFrame: Postoperative 5 years
Other outcomes:
measure: Start drinking and eating time (hours)
timeFrame: During the time in the hospital. Up to 30 days post operation.
measure: Time for recovery of gastrointestinal function (defecation or exhaust)(hours)
timeFrame: During the time in the hospital. Up to 30 days post operation.
measure: The time for starting to walk.
timeFrame: During the time in the hospital. Up to 30 days post operation.
measure: The standard time of postoperative discharge preparation ____ (hours)
timeFrame: During the time in the hospital. Up to 30 days post operation.
measure: Drainage tube and fluid.
timeFrame: During the time in the hospital. Up to 30 days post operation.
measure: Local anesthetic toxicity
timeFrame: During the time in the hospital. Up to 30 days post operation.
measure: Nausea and vomiting:
timeFrame: During the time in the hospital. Up to 30 days post operation.
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: