Intraperitoneal Lidocaine in Ovarian Cancer Surgery

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05450055
• Other study ID #: M2021589
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: July 30, 2029

Study information

• Verified date: July 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 30, 2029
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Pain, Postoperative
• Post Operative Pain

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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