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

NCT ID: NCT02223533

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Wound catheter

analgesia with wound catheter after colon surgery

Group Type: EXPERIMENTAL

19Gx500-mm Pajunk InfiltraLong® catheter

Intervention Type: 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

analgesia with morphine after colon surgery

Group Type: ACTIVE_COMPARATOR

morphine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

morphine

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Galdakao-Usansolo

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sorkunde Telletxea, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sorkunde Telletxea, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Galdakao-Usansolo

Locations

Hospital de GAldakao-Usansolo

Usansolo, Biscay, Spain

Countries

Spain

Other Identifiers

sork-2011111058

Identifier Type: -

Identifier Source: org_study_id