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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02223533
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sorkunde Telletxea, MD, PhD, Hospital Galdakao-Usansolo

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Device: 19Gx500-mm Pajunk InfiltraLong® catheter Drug: morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia With Interfascial Continuous Wound Infiltration of a Local Anaesthetic vs Intravenous Opioids After Laparoscopic Colon Surgery: A Randomized Clinical Trial.
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wound catheter
analgesia with wound catheter after colon surgery
Device: 19Gx500-mm Pajunk InfiltraLong® catheter
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.

Active Comparator: morphine
analgesia with morphine after colon surgery
Drug: morphine
After the intervention patients had access to intravenous morphine via a patient-controlled analgesia




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223533


Locations
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Spain
Hospital de GAldakao-Usansolo
Usansolo, Biscay, Spain, 48960
Sponsors and Collaborators
Hospital Galdakao-Usansolo
Investigators
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Principal Investigator: Sorkunde Telletxea, MD, PhD Hospital Galdakao-Usansolo
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Responsible Party: Sorkunde Telletxea, MD, PhD, MD, PhD, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT02223533    
Other Study ID Numbers: sork-2011111058
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Sorkunde Telletxea, MD, PhD, Hospital Galdakao-Usansolo:
analgesia
post-operative
wound catheter infusion
laparoscopic colon surgery
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents