Ovarian CancerNCT05450055
Intraperitoneal Lidocaine in Ovarian Cancer Surgery
A study of Ovarian Cancer and Post Operative Pain, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, Post Operative Pain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2022to 30 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer, Post Operative Pain
- Being tested
- intraperitoneal lidocaine analgesic or normal saline as control
- Keywords
- Postoperative intraperitoneal lidocaine, Intraperitoneal analgesic, Ovarian cancer, Prognosis
- Medical subject headings
- Ovarian Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal lidocaine analgesic or normal saline as controlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| intraperitoneal analgesic group | Experimental | 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. Receives: Procedure: intraperitoneal lidocaine analgesic or normal saline as control |
| control group | Placebo comparator | 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. Receives: Procedure: intraperitoneal lidocaine analgesic or normal saline as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: Postoperative 72 hours
Secondary outcomes (4)
Survival time (months)
Postoperative survival time (months).
Measured: Postoperative 5 years
Disease free survival time (months)
Time between surgery to cancer relapse (months).
Measured: Postoperative 5 years
Recurrence (yes/no, if yes ,record recurrence date)
Whether the cancer relapse.
Measured: Postoperative 5 years
Postoperitive chronic pain duration (months)
Postoperitive chronic pain duration (months), if present, record the location of the pain.
Measured: Postoperative 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start18 Jul 2022 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450055
- Sponsor's protocol ID
- M2021589
- Status last verified
- Jul 2022
- First submitted
- 31 May 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Investigate Effect of Postoperative Intraperitoneal Lidocaine on the Analgesic and Prognosis of Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05450055
- Acronym / sponsor ID
- M2021589
- Conditions
- Ovarian Cancer, Post Operative Pain
- Keywords
- Postoperative intraperitoneal lidocaine, Intraperitoneal analgesic, Ovarian cancer, Prognosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 18 Jul 2022 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intraperitoneal analgesic group | Experimental | Procedure: intraperitoneal lidocaine analgesic or normal saline as controlBefore 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. |
| control group | Placebo comparator | Procedure: intraperitoneal lidocaine analgesic or normal saline as controlBefore 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraperitoneal lidocaine analgesic or normal saline as controlBefore 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. | Procedure or surgery | control group, intraperitoneal analgesic group |
Primary outcome
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)].
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Ovarian Cancer and Post Operative Pain, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic use (time frame: Postoperative 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.