Intraperitoneal Lidocaine in Ovarian Cancer Surgery

NCT05450055 | Not Yet Recruiting DMC

• 1 other identifier: M2021589
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Post Operative Pain

Keywords

Postoperative intraperitoneal lidocaine; Intraperitoneal analgesic; Ovarian cancer; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Survival time (months)

  Postoperative 5 years

• Disease free survival time (months)

  Postoperative 5 years

• Recurrence (yes/no, if yes ,record recurrence date)

  Postoperative 5 years

• Postoperitive chronic pain duration (months)

  Postoperative 5 years

Other Outcomes (7)

• Start drinking and eating time (hours)

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

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

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

• The time for starting to walk.

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

Study Arms (2)

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.

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.

Procedure: intraperitoneal lidocaine analgesic or normal saline as control

Interventions

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.

control group; intraperitoneal analgesic group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: July 8, 2022
• Study Start: July 18, 2022
• Primary Completion: July 30, 2024
• Study Completion (Estimated): July 30, 2029
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

CN (1)