Multimodal Analgesia With Interfascial Continuous Wound Infiltration: A Randomized Clinical Trial

Study Overview
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Brief Summary
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Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan can help control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects. Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital. Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and amount of intravenous morphine used via patient controlled infusion.

Official Title
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Multimodal Analgesia With Interfascial Continuous Wound Infiltration of a Local Anaesthetic vs Intravenous Opioids After Laparoscopic Colon Surgery: A Randomized Clinical Trial.

Conditions
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Pain

Intervention / Treatment
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* Device: 19Gx500-mm Pajunk InfiltraLong® catheter
* Drug: morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were eligible for the study if they were aged 18 years or older, with an American Society of Anesthesiologists (ASA) 14 grade of I to IV (anaesthetic risk), were scheduled to undergo laparoscopic colon surgery, and voluntarily agreed to participate by signing an informed consent form. Exclusion Criteria: Patients were excluded if they were allergic to amides or pyrazolones, were likely to require conversion to open surgery with laparotomy, were long-term users of opioids, required emergency surgery, were unable to participate due to cognitive deterioration, or declined to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound catheter<br>analgesia with wound catheter after colon surgery | Device: 19Gx500-mm Pajunk InfiltraLong® catheter<br>* Before completing the surgery, the surgical team inserted a 19Gx500-mm Pajunk InfiltraLong® catheter with multiple perforations in the last few centimeters before the tip to allow for local anesthetic administration.<br>|
| Active Comparator: morphine<br>analgesia with morphine after colon surgery | Drug: morphine<br>* After the intervention patients had access to intravenous morphine via a patient-controlled analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Numerical Rating Pain Scale (NRS) after laparoscopic colon surgery using interfascial continuous wound infiltration | Numerical Rating Pain Scale was used to measure the after-intervention Pain. This scale is widely used and shows good correlation with the Visual Analogue scale, specifically in the case of elderly individuals. Compared to other scales, it has low error rates and high validity. This score was assessed in all the participants. | Over the 48 hours after laparoscopic colon surgery | 
| Assessment of intravenous morphine consumption after laparoscopic colon surgery | Intravenous morphine consumption was administrated via patient-controlled analgesia device. The consumption was evaluated in all participants in the study at the following measurement points: at 30 min, 2h, 8h, 24h, and 48h after the intervention. | Over the 48 hours after laparoscopic colon surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to intravenous morphine consumption | Complications related to intravenous morphine consumption were measured: nausea, vomiting and pruritus throughout the treatment period. Paralytic ileus awas measured 24h after surgery. This was assessed for all patients. Moreover, especially for patients belonging to the experimental group, potential adverse effects from placement of the wound catheter such as infection or haematoma at the surgical site or potential toxicity of local anesthetic (e.g., tinnitus, obnubilation) were recorded. | Over the 48 hours after laparoscopic colon surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, post-operative, wound catheter infusion, laparoscopic colon surgery