Intraperitoneal Lidocaine in Ovarian Cancer Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer; Post Operative Pain
• Intervention / Treatment: Procedure: intraperitoneal lidocaine analgesic or normal saline as control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intraperitoneal analgesic group; 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. Patients in both groups were routinely given flurbiprofen axel 50mg intravenously for analgesia. Local infiltration anesthesia was performed with 20mL 1% lidocaine at the incision area. 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. At the same time, patients in both groups were connected with intravenous controlled intravenous controlled analgesia (PCIA) : sufentanil 100µg to 100mL normal saline, background dose of 2mL/h, single push injection of 0.5mL, locked for 15 minutes.	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 720mL in the pump.
Placebo Comparator: control group; Before the end of surgery, patients in the control group (C group) were extensively sprayed with 20mL normal saline intraperitoneally before the peritoneum was sutured. The surgeon placed an intraperitoneal catheter with the catheter tip above the vaginal end while placing percutaneous drainage tube. Patients in both groups were routinely given flurbiprofen axel 50mg intravenously for analgesia. Local infiltration anesthesia was performed with 20mL 1% lidocaine at the incision area. In the control group, 0.9% normal saline was injected intraperitoneally with 10mL/h, and the total volume in the pump was 720mL. At the same time, patients in both groups were connected with intravenous controlled analgesia pump (PCIA) : sufentanil 100µg to 100mL normal saline, background dose of 2mL/h, single push injection of 0.5mL, locked for 15 minutes.	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 720mL in the pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesic use	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)].	Postoperative 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival time (months)	Postoperative survival time (months).	Postoperative 5 years
Disease free survival time (months)	Time between surgery to cancer relapse (months).	Postoperative 5 years
Recurrence (yes/no, if yes ,record recurrence date)	Whether the cancer relapse.	Postoperative 5 years
Postoperitive chronic pain duration (months)	Postoperitive chronic pain duration (months), if present, record the location of the pain.	Postoperative 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Start drinking and eating time (hours)	Time when the patients start drinking and eating.	During the time in the hospital. Up to 30 days post operation.
Time for recovery of gastrointestinal function (defecation or exhaust)(hours)	Time to the patients bowel movement recover.	During the time in the hospital. Up to 30 days post operation.
The time for starting to walk.	Record the time of walk with attendant assistance (hours), and by theirselves____ (hours).	During the time in the hospital. Up to 30 days post operation.
The standard time of postoperative discharge preparation ____ (hours)	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.	During the time in the hospital. Up to 30 days post operation.
Drainage tube and fluid.	Drainage tube removal time ____(hours), drainage volume ____(ml), drainage flow character ____(color/transparent/other).	During the time in the hospital. Up to 30 days post operation.
Local anesthetic toxicity	Frequency of occurrence: Times of occurrence (number) The time of occurrence from surgery (hours) Symptoms (record) Treatment (record)	During the time in the hospital. Up to 30 days post operation.
Nausea and vomiting:	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.	During the time in the hospital. Up to 30 days post operation.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 18, 2022
• Primary Completion (Anticipated): July 30, 2024
• Study Completion (Anticipated): July 30, 2029

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Prognosis; Ovarian cancer; Postoperative intraperitoneal lidocaine; Intraperitoneal analgesic
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Postoperative Complications; Pain; Neurologic Manifestations; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Pain, Postoperative; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Analgesics
• Other Study ID Numbers: M2021589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No