CLoWI Versus PCA Morphine for Pain Control After Major Abdominal Surgery

NCT04503720 | Completed DMC

• 1 other identifier: Juronghealth
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

Major abdominal surgery is associated with significant complications which may lead to morbidity and mortality. Pain experienced after surgery affects the recovery from surgery. Our study aims to evaluate the current gold standard of PCA morphine infusion against a continuous wound infusion (CLoWI). The use of CLoWI negates the side-effects of opioids, and will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).

Conditions

Surgical Wound; Post-Op Complication; Opioid Use

Keywords

continuous local wound infusion; opioids; post-operative pain; surgical incision

Outcome Measures

Primary Outcomes (1)

• To compare CLoWI and PCA (Morphine) in terms of post operative pain control

  To determine if wither CLoWI or PCA will achieve better post-operative pain control based on a numerical rating score from 0 - 10

  5 days

Secondary Outcomes (2)

• To compare CLoWI and PCA (Morphine) in terms of post operative complication rates associated with opioid usage

  5 days

• To compare CLoWI and PCA (Morphine) in terms of the length of postoperative hospital stay.

  from the time of surgery till discharge, an average of 5 days

Study Arms (2)

CLoWI

EXPERIMENTAL

CLoWI (ropivacaine) and PCA (normal saline) The local anaesthetic infusion will be administered via 2 catheters using a ON-Q® (Halyard) delivery system that will be placed under direct vision by the surgeon at the time of wound closure. 40 mls of 0.25% ropivacaine are infiltrated in the preperitoneal plane. 0.5% ropivacaine will be infused at a rate of 4mls/hour (2mls/hour in each catheter). The dosage 40 mls of 0.25% ropivacaine and 0.5% ropivacaine at 4mls/hr (20mg/hr) over 4 days will be less than the recommended toxic dose of 3-4 mg/kg.

Device: CLoWI

PCA

ACTIVE COMPARATOR

PCA (Morphine) and CLoWI (normal saline) Morphine will be administered via the standard PCA protocol in accordance to the hospital's Acute Pain Service Programme: * Concentration: 1mg/ml * Bolus (Loading): 1mg * Lockout Interval: 5 minutes * Maximum hourly dose of 10mg

Device: PCA

Interventions

CLoWI DEVICE

Patients will receive a continuous wound infusion with ropivacaine and normal saline in the PCA pump.

CLoWI

PCA DEVICE

Patients will receive a continuous wound infusion with normal saline and morphine in the PCA pump.

PCA

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for elective or urgent# open abdominal surgery
• Abdominal Surgery may include the following procedures:
• A) Urgent laparotomy for perforated viscus, intestinal obstruction. B) Elective abdominal surgery for upper and lower gastrointestinal surgery
• Ability to provide informed consent. A signed and dated written informed consent prior to study participation.
• Age 21 to 80 years for both males and females

You may not qualify if:

• Female subject who is pregnant
• Inability to comply with PCA instructions due to physical disabilities. For example, visual or hearing impairment, arthritis, peripheral neuropathy.
• Known allergy to local anaesthetic or opioid drugs (Morphine).
• Current or recent on opioid therapy. For example due to chronic pain illness, opioid (or other) drug abuse or recent surgery.
• Severe comorbid diseases including liver cirrhosis, renal failure requiring dialysis, Grade 4 NYHA (New Yoke Heart Association) heart failure, respiratory illness requiring NIV (Non-Invasive Ventilation), etc.
• Severe associated acute illness American Society of Anesthesiologists (ASA) Grade 4 or 5 where survival following surgery is not expected

Sponsors & Collaborators

• JurongHealth: lead

Study Sites (2)

National University Hospital

Singapore, 119074, Singapore

Location

Ng Teng Fong General Hospital

Singapore, 609606, Singapore

Location

Related Publications (3)

• Liang SS, Ying AJ, Affan ET, Kakala BF, Strippoli GF, Bullingham A, Currow H, Dunn DW, Yeh ZY. Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults. Cochrane Database Syst Rev. 2019 Oct 19;10(10):CD012310. doi: 10.1002/14651858.CD012310.pub2.

  PMID: 31627242 BACKGROUND

• Prochazka V, Svoboda M, Svaton R, Grolich T, Farkasova M, Kala Z. Use of preperitoneal wound catheter for continuous local anaesthesia after laparoscopic colorectal surgery. Rozhl Chir. 2019 Summer;98(9):356-361. doi: 10.33699/PIS.2019.98.9.356-361.

  PMID: 31698911 BACKGROUND

• Dalmau A, Fustran N, Camprubi I, Sanzol R, Redondo S, Ramos E, Torras J, Sabate A. Analgesia with continuous wound infusion of local anesthetic versus saline: Double-blind randomized, controlled trial in hepatectomy. Am J Surg. 2018 Jan;215(1):138-143. doi: 10.1016/j.amjsurg.2017.09.007. Epub 2017 Sep 20.

  PMID: 28958651 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Postoperative Complications; Pain, Postoperative

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Christopher Keh, FRCS

  Ng Teng Fong General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: August 7, 2020
• Study Start: December 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)