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NCT Number: NCT02223533

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

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de GAldakao-Usansolo

Usansolo, Biscay, 48960, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

19Gx500-mm Pajunk InfiltraLong® catheter

Device

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.

Morphine

Drug

After the intervention patients had access to intravenous morphine via a patient-controlled analgesia

Primary outcomes

  1. Assessment of Numerical Rating Pain Scale (NRS) after laparoscopic colon surgery using interfascial continuous wound infiltration

    Time frame: Over the 48 hours after laparoscopic colon surgery

    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.

  2. Assessment of intravenous morphine consumption after laparoscopic colon surgery

    Time frame: Over the 48 hours 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.

Secondary outcomes

  1. Complications related to intravenous morphine consumption

    Time frame: Over the 48 hours after laparoscopic colon surgery

    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.

Sponsors and collaborators

Lead sponsor

Hospital Galdakao-Usansolo

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 22, 2014
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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