- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645304
Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy (PAIN)
Postoperative Analgesic Efficacy of Continuous Wound Infusion With Local Anesthetics After Laparoscopy (PAIN): a Randomized, Double-blind, Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic surgery has become an acceptable alternative for open surgery in treating benign gynecologic diseases. One of most important advantages of laparoscopy is a reduced postoperative pain compared with open surgery. Moreover, postoperative pain plays an important part in the enhanced recovery after surgery (ERAS) pathway. Although the length of hospitalization and recovery period after laparoscopy tends to be shorter, postoperative pain can still be an important issue.
Recently, continuous wound infusion (CWI) providing a constant flow of local anesthetic directly a surgical wound postoperatively has been widely used to reduce pain after cesarean section and open surgery. Studies evaluating the effectiveness of 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 ERAS, compared with placebo in patients undergoing benign gynecologic laparoscopy.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Naehyun Lee, MD
- Phone Number: +821064212996
- Email: naehyuns@hanmail.net
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-746
- Recruiting
- Kangbuk Samsung Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ropivacaine group
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 .
|
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.
ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA)
|
Placebo Comparator: 0.9% Saline group
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 .
|
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain
Time Frame: 24-hour after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of rescue analgesics
Time Frame: within 3days after surgery
|
Rescue analgesia (75 mg diclofenac sodium administered intramuscularly or 25mg pethidine intramuscularly) was provided upon participant request
|
within 3days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-05-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Gynecologic Neoplasm
-
University of Campania "Luigi Vanvitelli"CompletedBenign Gynecologic NeoplasmItaly
-
Assiut UniversityUnknownBenign Gynecologic NeoplasmEgypt
-
Manipal UniversityCompletedHysterectomy | Benign Gynecologic Neoplasm | Minimal Invasive Surgery
-
Hyun ParkRecruiting
-
Massachusetts General HospitalRecruitingMalignant Neoplasm | Benign NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingCancer | Tumor | Benign Neoplasms | Carcinogens | Neoplasm, BenignUnited States
-
Hanyang University Seoul HospitalUnknownBenign Neoplasm | Pathology
-
University Hospital, ToulouseCompletedNeoplasm, Uncertain Whether Benign or MalignantFrance
-
Asan Medical CenterOlympusCompletedBenign Neoplasm of Body of Pancreas | Benign Neoplasm of Tail of Pancreas
-
University of Medicine and Pharmacy at Ho Chi Minh...RecruitingBenign Neoplasm | Mandible | Virtual Surgical PlanningVietnam
Clinical Trials on Ropivacaine
-
Ziekenhuis Oost-LimburgNot yet recruitingAnesthesia | Hallux Valgus
-
University Health Network, TorontoUnknownPIB Versus CI Through a Popliteal Sciatic Nerve Catheter for Analgesia Following Major Ankle SurgeryPain, PostoperativeCanada
-
Northwestern UniversityCompletedPostoperative PainUnited States
-
Hospices Civils de LyonCompleted
-
Pusan National University HospitalCompletedHemodynamics | Epidural Anesthesia | Ropivacaine ConcentrationKorea, Republic of
-
Northwestern UniversityCompletedObesity | Postoperative Pain | PregnancyUnited States
-
San Gerardo HospitalIRCCS Policlinico S. Matteo; University of Milano Bicocca; Azienda L'ULSS 15... and other collaboratorsCompletedLaparoscopic CholecystectomyItaly
-
Universiteit AntwerpenCompleted
-
China Medical University, ChinaWithdrawn
-
China Medical University, ChinaCompleted