Comparative Analysis of Multimodal Analgesia and EOI Plane Block in Open Liver Resection Patients

Explanation for the choice of comparators {6b}

At the Peking Union Medical College Hospital, the standard protocol for perioperative pain management among patients undergoing open liver resection is grounded in a multimodal analgesic approach, intentionally excluding regional anaesthesia. Following the surgical procedure, patients typically engage in opioid-based patient-controlled analgesia (PCIA) complemented by a variety of adjuvant medications. These include non-steroid anti-inflammatory drugs, acetaminophen, tramadol, and additional opioids as required. This established regimen serves as the primary comparator to assess the effectiveness of the EOI plane block in enhancing postoperative pain relief, minimizing opioid dependency, and facilitating quicker recoveries post-surgery.

To ensure the integrity of the study’s blinding process, all participants will receive local infiltration anaesthesia comprising 1 ml of 1% lidocaine. Within this framework, participants assigned to the intervention group will undergo the EOI plane block procedure, whereas those in the control group will not be administered this block.

Intervention description {11a}

Prior to the surgical intervention, participants will be accommodated in the pre-anaesthesia room, where they will be subject to rigorous monitoring protocols, which include non-invasive blood pressure checks, continuous electrocardiography, and pulse oximetry readings. Supplemental oxygen will be delivered through a nasal cannula for respiratory support. Additionally, an initial dose of 1 to 2 mg of midazolam will be administered to ease preoperative anxiety. A radial arterial catheter will be inserted to enable continuous monitoring of arterial blood pressure, as well as facilitating arterial blood gas analyses during the surgical procedure. Blood samples to assess plasma concentrations of ropivacaine will be collected using this catheter.

Approximately 30 minutes following the administration of local anaesthetic, participants will be transferred to the operating room. Continual monitoring will be implemented to include electrocardiography, pulse oximetry, bispectral index analysis, and invasive blood pressure measurements. General anaesthesia will be initiated with propofol at a dosage of 2 to 2.5 mg per kg, complemented by sufentanil (0.15 μg/kg) and rocuronium (0.6 mg/kg), after which endotracheal intubation and mechanical ventilation will commence. To maintain the level of general anaesthesia, a mixture of 2 to 3 vol% sevoflurane/oxygen/air will be inhaled, alongside a continuous infusion of sufentanil (0.1 μg/kg/h), remifentanil (0.1 to 0.2 μg/kg/min), and rocuronium (0.1 to 0.2 mg/kg /h). Care will be taken to keep hemodynamic fluctuations within a controlled range of 20% from baseline values.

Criteria for discontinuing or modifying allocated interventions {11b}

Participants may withdraw from the study at any stage should they choose. The associated risks with the ultrasound-guided EOI plane block are regarded as minimal, particularly since no complications related to this procedure have been documented in existing literature. In cases of any complications arising, appropriate medical interventions will be promptly administered. Participants who express a desire to continue participation despite any issues will remain within their assigned study group.

Relevant concomitant care permitted or prohibited during the trial {11d}

Postoperative pain management modalities, including opioids, non-steroid anti-inflammatory drugs, acetaminophen, tramadol, and other analgesics, are permitted. Nonetheless, any form of regional anaesthesia is strictly prohibited, including techniques such as wound infiltration, transversus abdominis plane block, quadratus lumborum blocks, paravertebral blocks, erector spinae plane blocks, and thoracic epidural analgesia.

Outcomes {12}

Primary outcome

Secondary outcomes include

1. (1)

   NRS pain scores at rest and during movement at postoperative 6, 24, 48, and 72 h, and during movement at postoperative 3 h.

2. (2)

   Perioperative opioid consumption.

3. (3)

   Remedial analgesics within 72 h postoperatively.

4. (4)

   PCIA pump usage within 72 h postoperatively.

5. (5)

   Recovery milestones, including time to removal of urinary catheter, time to first ambulation, time to first flatus, and length of hospital stay.

6. (6)

   Postoperative side effects, such as nausea, vomiting, dizziness, drowsiness, and pruritus.

7. (7)

Exploratory outcome

Participant timeline {13}

The participant timeline is illustrated in Fig. 2.

Fig. 2

Schedule of enrolment, interventions, and assessment (SPIRIT figure). EOI, external oblique intercostal

Sample size {14}

The sample size for the study was derived from a preliminary pilot investigation involving 8 participants. The findings indicated that the mean resting pain score at 3 h postoperatively was 3.5 (± 1.3) in the control group compared to 2.8 (± 0.5) in the intervention group. To achieve a statistical power of 0.80 with a two-sided α level of 0.05, a minimum sample size of 33 participants in each group was determined to be necessary. Considering a dropout rate of about 10%, the recruitment target has been adjusted to 37 participants per group.

Recruitment {15}

All participants are inpatients scheduled for elective open liver surgery. The day prior to surgery, an investigator will scrutinize the surgery schedule to pinpoint eligible subjects. Individuals meeting all inclusion parameters and devoid of exclusion criteria will qualify for the study. The investigator will provide thorough explanations of the study to the participants and their families, subsequently obtaining informed consent. A collaborative effort between the anaesthesiology and liver surgery departments promotes effective participant recruitment.

The Painful Decision: Analyzing Perioperative Pain Management

Alright, dear readers, let’s take a plunge into the world of perioperative pain management like we’re diving into a pool of ice – a little shocking, but ultimately refreshing! Now, why does this matter? Well, if you’re undergoing surgery, you want to know that the pain management plan for your post-op recovery is better than a soggy biscuit — I mean, naan of this nonsense!

Why Comparators Matter {6b}

At Peking Union Medical College Hospital, they’re jolly keen on multimodal analgesia without a side of regional anaesthesia. That means after a good old liver resection (hooray!), patients get to sample the sweet, sweet sorrow of opioid-based patient-controlled analgesia (PCIA) – like a trusty sidekick on a superhero mission. But wait, we’re really doing this study to see if the EOI plane block serves up that postoperative analgesia like it’s a Michelin-starred dish! You know, less opioid consumption and all-around better recovery. Who wouldn’t want that?

Intervention Description {11a}

Before the big cutting begins, participants will be whisked away to a pre-anaesthesia rom-com starring midazolam, blood pressure monitors, and all the fancy machines you’ve only seen in your friend’s tech-packed garage. And if that’s not enough, there’s an arterial catheter in the mix – because why wouldn’t we want to keep a close eye on your blood pressure while making you unconscious? Talk about playing it safe!

Discontinuation Criteria {11b}

Worried about discomfort? Fear not! If participants experience any shenanigans — and they’re free to bow out at any point. No one’s chaining you to the hospital bed! Low-risk for ultrasound-guided EOI plane block sounds good, but if something goes south, rest assured, medical treatment will be flung at you faster than you can say “complication.” Spoiler alert: you still get to stick with the same study group, like an exclusive club where everyone’s collectively moaning about pain.

Strategies for Adherence {11c}

Concomitant Care Allowed or Not {11d}

Here’s the kicker: you can take all the pain meds you want after surgery, but don’t even think about mixing your regional anaesthesia drinks! Those fancy regional blocks? Off the menu, my friend! But paracetamol and tramadol? Oh yes, please! Because what’s life without a bit of medicinal mash-ups?

Post-Trial Provisions {30}

Like a bad horror movie setup, there’s no escaping what’s to come after the trial. You’ve climbed the surgical mountain, and now the post-trial aftermath is yours to deal with. But worry not, there’ll be provisions, just not the kind you want at a sad buffet.

Outcomes {12}

Primary Outcome

Secondary Outcomes Include

1. NRS pain scores: Measured at 6, 24, 48, and 72 hours. Because pain likes to time travel!

2. Perioperative opioid consumption: Finally, let’s see how much we really need to dull the pain.

3. Remedial analgesics: Keep track of all medications like a well-conducted orchestra.

4. PCIA pump usage: From the automatic machines that sadly ran out of juice!

5. Recovery milestones: From the reassuring “I can stand!” to “Hey, I just farted!”

6. Postoperative side effects: Expect the unexpected: nausea, dizziness, or suddenly feeling like you could take on the world!

Exploratory Outcome

What’s exploration without a roadmap, eh? The participant timeline may look like the plot of “Lost” with a lot fewer castaways, but it’s vital to understanding the journey — stay tuned for results and insights from Fig. 2, your visual aid of heroism!

Sample Size Calculations {14}

For our number crunching experts out there, they sampled data of 8 participants and worked their math magic. With a number in mind, you are to see 37 participants aiming for a robust conclusion – and maybe, just maybe, save a few more livers flipping pancakes in the morning.

Recruitment Methods {15}

And for our grand finale, we’ve got the recruitment strategy. It’s like casting for a blockbuster movie – carefully selecting patients for elective surgeries and wooing them into participation like a charm offensive. Ensuring each one is ready to sign their life away for the sake of science — who could resist that thrill?

So there you have it! A peek into the wild world of perioperative pain management. As long as medical wizards are cooking up better and less painful outcomes, there’s hope for everyone going under the knife. Just remember to ask for the good meds and enjoy the ride.

Tions‍ administered postoperatively. We want to ​ensure that ‍we’re not ​overshooting​ or undershooting that sweet analgesic spot!

Time to first analgesic request: Measures how quickly patients are begging for relief after surgery. It’ll help ⁣us understand how effective our interventions really​ are.

Patient satisfaction​ scores: Because ‍at the end of the ​day, we all want to be happy campers, even post-surgery!

Postoperative side effects: Such as nausea, vomiting, dizziness, drowsiness, and‌ pruritus. We’re keeping a close ‍eye on those unwanted bonus features that come⁤ with surgery.

Exploratory Outcome

In addition to the main outcomes, we’re also ⁢looking at exploratory outcomes ‌to delve ‍deeper into the effects of our interventions and ⁢the overall recovery ⁣experience.

Participant Timeline

To visualize ⁣the entire participant experience, you can take a gander⁢ at Fig. 2,⁤ which beautifully illustrates the schedule of enrollment, interventions,⁢ and assessments – sort‍ of⁢ like a road map to recovery!

Sample Size

For the scientifically inclined, the preliminary pilot investigation showed promising differences in pain scores ⁣between groups. With our sample​ size calculations, ​we determined that a total of 33 participants per group⁢ would give‌ us enough power to make statements about our findings. When we add in a ‌healthy⁤ 10% ​dropout rate, we’re aiming for 37 participants in each ‍group⁢ to keep⁣ our statistical ship sailing smoothly.

Recruitment

We’re targeting inpatients scheduled for elective ‌open liver surgeries. The ​day‍ before the operation, investigators will sift through the surgery schedule to find eligible candidates. After thorough discussions and obtaining informed consent, we’ll ensure our participants understand what’s coming their way, with the backing of both anaesthesiology and liver surgery ‌departments for a‌ smooth ⁣sailing recruitment ⁤process.

Conclusion

So there you have it! A humorous yet insightful look into our⁣ study on perioperative pain management. By embracing multimodal analgesia and innovating with techniques like the EOI plane ​block, we’re ‌hopeful that we⁢ can enhance recovery while minimizing the need for opioids.⁣ Here’s to a pain-free surgery experience for everyone!