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

H

Hospital Galdakao-Usansolo

Status and phase

Completed
Phase 4

Conditions

Pain

Treatments

Device: 19Gx500-mm Pajunk InfiltraLong® catheter
Drug: morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT02223533
sork-2011111058

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Wound catheter
Experimental group
Description:
analgesia with wound catheter after colon surgery
Treatment:
Device: 19Gx500-mm Pajunk InfiltraLong® catheter
morphine
Active Comparator group
Description:
analgesia with morphine after colon surgery
Treatment:
Drug: morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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