A Study Comparing the Effects of Different Methods of Administering Pain Relief for Standard Procedures for Malignant Pleural Mesothelioma

JRCT ID: jRCT1051240111

Registered date:20/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant Pleural Mesothelioma
• Date of first enrollment: 18/04/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Using a random number table, the study patients were divided into two groups: one group received continuous local anesthesia via a continuous nerve block catheter from the beginning of surgery (intraoperative and postoperative groups), and the other group received continuous local anesthesia via a catheter from the end of surgery (postoperative group).
Both groups will receive general anesthesia.
After induction of general anesthesia, the patient is placed in the supine position with the surgical side up, and after confirming that the double lumen tube is in the correct position, one lung ventilation is performed using only the healthy lung.
After positional change, a single transverse interproximal block is performed in both groups, and a continuous catheter is placed.
For the single block, 20 ml of 0.25 percent levobupivacaine hydrochloride (popskaine) is used.
Intraoperative and postoperative group is 0.125 percent popskaine will be administered at 4 ml/H via catheter from the start of surgery.
From the time of wound closure, continuous administration of 300 ml (150 ml 0.25percent popskaine and 150 ml saline) at 4 ml/h through the catheter will be continued during surgery using an infusion pump, which is a container containing chemicals connected to the catheter.
Postoperative group is 300 ml of 0.25 percent popskine 150 ml and 150 ml of saline solution will be continuously administered at 4 ml/h using an infusion pump, which is a container containing chemicals connected to a catheter.
Both groups will receive 40 micro g/kg granisetron hydrochloride (product name: granisetron) as prophylaxis for postoperative nausea and vomiting.
Both groups will receive 15 mg/kg of acetaminophen before the end of surgery.
The patients will be extubated after confirming the effect of muscle relaxants with a muscle relaxation monitor and administering sugamadex sodium as needed before extubation in both groups.
The management after the next day of surgery is described below.
If the NRS, an assessment of pain, worsens despite the additional analgesia described above, both groups will receive Patient Controlled Analgesia (PCA), a higher but safer dose of medication than the continuous dose given by pressing a button connected to the catheter in the event of pain worsening. The patient is given a larger but safer dose than the continuous dose through the catheter by pushing a button connected to the catheter during a pain exacerbation. If the NRS nevertheless worsens, continuous IV fentanyl may be started at 1 ml/h (25 micro g/h) at the discretion of the intensive care unit physician. If the NRS is still worsening after initiation, a bolus dose of fentanyl (12.5 micro g) is administered, which is an additional dose of fentanyl at the time of pain exacerbation.
In both groups, postoperative analgesia is administered until the contents of the infusion pump are empty.

In this study, the dosage of local anaesthetics varies between groups, but is within the scope of insurance coverage and is used within the indications.

Outcome(s)

• Primary Outcome: The assessment of postoperative quality of life

Secondary Outcome

1.Visual Analog Scale (VAS) at rest and during movement at 1 hour, 24 hours, 48 hours, and 72 hours
postoperatively.
2.Numerical Rating Scale (NRS) at rest and during movement at 1 hour, 24 hours, 48 hours, 72 hours, 6 months, and 1 year postoperatively.
3.Intraoperative blood loss.
4.Perioperative opioid usage.
5.Postoperative Patient-Controlled Analgesia (PCA) usage from the continuous catheter.
6.Presence of postoperative nausea and vomiting.
7.Perioperative blood pressure fluctuations and use of vasopressors.
8.Postoperative oxygen supplementation, presence of respiratory complications.
9.Inflammatory markers (CRP, white blood cell count) in blood samples taken the day after surgery.
10.Duration of stay in the intensive care unit, time to ambulation, length of hospital stay postoperatively.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients over 20 years old who will be scheduled for pleurectomy/decortication surgery at the Surgical Center of Hyogo Medical University Hospital during the period from the date of approval to April 30, 2026,
who have consented for the placement of a continuous catheter for postoperative pain management,
and who have also agreed to participate in the research.

Exclude criteria

1.Patients with American Society of Anesthesiologists Physical Status Classification (ASA-PS) of IV or above
2.Patients with severe dementia, difficult to make postoperative assessment
3.Patients with a history of chronic pain or regularuse opioid
4.Patients at high risk of bleeding

Related Information

• Primary Sponsor: Kobata Mayuu