Ovarian Cancer, Post Operative Pain
Conditions
Keywords
Postoperative intraperitoneal lidocaine, Intraperitoneal analgesic, Ovarian cancer, Prognosis
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.
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.
Interventions
PROCEDUREintraperitoneal 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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesic use | 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\[sufentanil (µg)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time (months) | Postoperative 5 years | Postoperative survival time (months). |
| Disease free survival time (months) | Postoperative 5 years | Time between surgery to cancer relapse (months). |
| Recurrence (yes/no, if yes ,record recurrence date) | Postoperative 5 years | Whether the cancer relapse. |
| Postoperitive chronic pain duration (months) | Postoperative 5 years | Postoperitive chronic pain duration (months), if present, record the location of the pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local anesthetic toxicity | 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) |
| Start drinking and eating time (hours) | During the time in the hospital. Up to 30 days post operation. | Time when the patients start drinking and eating. |
| Nausea and vomiting: | 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. |
| Time for recovery of gastrointestinal function (defecation or exhaust)(hours) | During the time in the hospital. Up to 30 days post operation. | Time to the patients bowel movement recover. |
| The time for starting to walk. | 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). |
| The standard time of postoperative discharge preparation ____ (hours) | 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. |
| Drainage tube and fluid. | 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). |
Countries
China
Outcome results
None listed