Intraperitoneal Lidocaine in Ovarian Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intraperitoneal lidocaine analgesic or normal saline as control.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Post Operative Pain. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial to Investigate Effect of Postoperative Intraperitoneal Lidocaine on the Analgesic and Prognosis of Patients With Ovarian Cancer
Overview
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.
Interventions
- Procedure intraperitoneal lidocaine analgesic or normal saline as control
Before the end of surgery, patients in the experimental group (L group) were extensively sprayed with 20mL (100mg) 0.5% lidocaine intraperitoneally before the peritoneum was sutured. The surgeon placed intraperitoneal catheter with the catheter tip above the vaginal end while placing percutaneous drainage tube. The intraperitoneal catheter was connected to the electronic analgesia pump, and the infusion of 0.5% lidocaine 10mL/h was interrupted from 1 to 72h after surgery, with a total volume of
Primary outcome measures
- Postoperative analgesic use [Time frame: Postoperative 72 hours]
Secondary outcome measures (4)
- Survival time (months) [Time frame: Postoperative 5 years]
- Disease free survival time (months) [Time frame: Postoperative 5 years]
- Recurrence (yes/no, if yes ,record recurrence date) [Time frame: Postoperative 5 years]
- Postoperitive chronic pain duration (months) [Time frame: Postoperative 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT05450055 · M2021589