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NCT Number: NCT05450055

Intraperitoneal Lidocaine in Ovarian Cancer Surgery

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Ovarian Diseases Ovarian Neoplasms Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraperitoneal lidocaine analgesic or normal saline as control

Procedure

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 720mL in the pump.

Primary outcomes

  1. Postoperative analgesic use

    Time frame: Postoperative 72 hours

    Postoperative intravenous analgesia pump pressing time (recording the time by the electronic analgesia pump) and times (including effective and ineffective pressing times, recording by numbers), intravenous analgesia pump drug usage[sufentanil (µg)].

Secondary outcomes

  1. Survival time (months)

    Time frame: Postoperative 5 years

    Postoperative survival time (months).

  2. Disease free survival time (months)

    Time frame: Postoperative 5 years

    Time between surgery to cancer relapse (months).

  3. Recurrence (yes/no, if yes ,record recurrence date)

    Time frame: Postoperative 5 years

    Whether the cancer relapse.

  4. Postoperitive chronic pain duration (months)

    Time frame: Postoperative 5 years

    Postoperitive chronic pain duration (months), if present, record the location of the pain.

Other outcomes

  1. Start drinking and eating time (hours)

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Time when the patients start drinking and eating.

  2. Time for recovery of gastrointestinal function (defecation or exhaust)(hours)

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Time to the patients bowel movement recover.

  3. The time for starting to walk.

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Record the time of walk with attendant assistance (hours), and by theirselves____ (hours).

  4. The standard time of postoperative discharge preparation ____ (hours)

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Postoperative discharge preparation standards include: Walk independently, gastrointestinal function (to eat, drink, defecate) returned to normal, with oral analgesics, appropriate control without a mild pain, symptoms of nausea and vomiting, a local infection (redness, tenderness) or systemic infection, fever, c-reactive protein or increase white blood cell count), no other complications (bleeding, respiratory dysfunction, Deep vein thrombosis, etc.

  5. Drainage tube and fluid.

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Drainage tube removal time ____(hours), drainage volume ____(ml), drainage flow character ____(color/transparent/other).

  6. Local anesthetic toxicity

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Frequency of occurrence: Times of occurrence (number) The time of occurrence from surgery (hours) Symptoms (record) Treatment (record)

  7. Nausea and vomiting:

    Time frame: During the time in the hospital. Up to 30 days post operation.

    Nausea and vomiting: Times of vomiting(number) The time of occurrence from surgery (hours) Treatment (record) Postoperative nausea score was recorded by numbers 0-3:0 = no nausea, 1= mild nausea and vomiting, which did not require drug treatment, 2= moderate nausea, which could be controlled by ondansetron, 3= severe nausea, which did not respond to ondansetron.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial to Investigate Effect of Postoperative Intraperitoneal Lidocaine on the Analgesic and Prognosis of Patients With Ovarian Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Jul 8, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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