Intraperitoneal Lidocaine in Ovarian Cancer Surgery

July 11, 2022 updated by: Peking University Third Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)].
Postoperative 72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival time (months)
Time Frame: Postoperative 5 years
Postoperative survival time (months).
Postoperative 5 years
Disease free survival time (months)
Time Frame: Postoperative 5 years
Time between surgery to cancer relapse (months).
Postoperative 5 years
Recurrence (yes/no, if yes ,record recurrence date)
Time Frame: Postoperative 5 years
Whether the cancer relapse.
Postoperative 5 years
Postoperitive chronic pain duration (months)
Time Frame: Postoperative 5 years
Postoperitive chronic pain duration (months), if present, record the location of the pain.
Postoperative 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
During the time in the hospital. Up to 30 days post operation.
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.
During the time in the hospital. Up to 30 days post operation.
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).
During the time in the hospital. Up to 30 days post operation.
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.
During the time in the hospital. Up to 30 days post operation.
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).
During the time in the hospital. Up to 30 days post operation.
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)
During the time in the hospital. Up to 30 days post operation.
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.
During the time in the hospital. Up to 30 days post operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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