Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy

NCT03645304 | Unknown

• 1 other identifier: 2018-05-014
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Studies evaluating the effectiveness of continuous wound infusion (CWI) to manage postoperative pain following laparoscopy are markedly lacking. Especially, there was no study comparing CWI and placebo in treating gynecologic laparoscopy. Therefore, the investigators conducted this randomized, double-blind, placebo-controlled trial to investigate whether CWI of local anesthetics was an effective strategy for enhanced recovery after surgery (ERAS), compared with placebo in patients undergoing benign gynecologic laparoscopy.

Conditions

Benign Gynecologic Neoplasm

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  The postoperative pain was measured using a visual analog scale (VAS) at 24 hours after surgery by several assessors who were blinded to the interventions. The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".

  24-hour after surgery

Secondary Outcomes (1)

• the number of rescue analgesics

  within 3days after surgery

Study Arms (2)

Ropivacaine group

EXPERIMENTAL

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the experimental group, an elastomeric pump filled with local analgesic solution (total volume 100ml) containing 750mg ropivacaine .

Drug: Ropivacaine; Device: ON-Q Painbuster Silver Soaker

0.9% Saline group

PLACEBO COMPARATOR

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the control group, an elastomeric pump filled with filled with 100ml of 0.9% saline .

Drug: 0.9% saline group

Interventions

Ropivacaine DRUG

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the experimental group, an elastomeric pump filled with local analgesic solution (total volume 100ml) containing 750mg ropivacaine . Ropivacaine is local analgesics.

Ropivacaine group

0.9% saline group DRUG

Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the control group, an elastomeric pump filled with filled with 100ml of 0.9% saline .

0.9% Saline group

ON-Q Painbuster Silver Soaker DEVICE

ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA)

Ropivacaine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years,
• American Society of Anesthesiologists physical status (ASAPS) classification I-II
• the absence of pregnancy at the time of surgery

You may not qualify if:

• allergy to amide local anesthetics including ropivacaine
• laparoscopic surgery needing ≥ 3 separate skin incisions
• history of ventral or incisional hernia
• pre-existing coagulopathy, neurologic or cognitive dysfunction
• systemic or regional (especially, umbilicus) infection
• previously taking opioids for acute or chronic pain
• inability to accurately express their pain.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Taejong Song, MD PhD

  Kangbuk Samsung Hospital, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taejong Song, MD PhD

CONTACT

+821040358405; taejong.song@gmail.com

Naehyun Lee, MD

CONTACT

+821064212996; naehyuns@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: August 24, 2018
• Study Start: January 21, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)