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

NCT02223533 | Completed Phase 4

• 1 other identifier: sork-2011111058
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

analgesia; post-operative; wound catheter infusion; laparoscopic colon surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Complications related to intravenous morphine consumption

  Over the 48 hours after laparoscopic colon surgery

Study Arms (2)

Wound catheter

EXPERIMENTAL

analgesia with wound catheter after colon surgery

Device: 19Gx500-mm Pajunk InfiltraLong® catheter

morphine

ACTIVE COMPARATOR

analgesia with morphine after colon surgery

Drug: morphine

Interventions

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.

Wound catheter

morphine DRUG

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

morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Hospital de GAldakao-Usansolo

Usansolo, Biscay, 48960, Spain

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sorkunde Telletxea, MD, PhD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 22, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

ES (1)