Novel Technique of Analgesia Following Open Liver Resection

NCT01960049 | Completed Phase 4

• 1 other identifier: 12-0493-A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.

Conditions

Postoperative Pain; Liver Resection

Keywords

Postoperative pain; Liver resection; Medial Open Transversus Abdominis Plane catheter

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  The primary endpoint is mean cumulative postoperative opioid consumption over the first two postoperative days (48 hours). Both intravenous PCA opioids and oral opioids will be recorded from the patient's medical records daily, converted to morphine equivalents, and compared between the two groups. The following information will be collected at regular intervals as a measure of the primary endpoints: Cumulative i.v. PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.

  PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.

Study Arms (2)

MOTAP Catheter with Saline and IV PCA

PLACEBO COMPARATOR

Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours

Procedure: saline and IV PCA

MOTAP catheter with ropivocaine and IV PCA

ACTIVE COMPARATOR

20cc of 0.2% ropivacaine will be injected in two equal divided doses through the two catheters then run at 5ml/hr for 72 hours

Procedure: ropivacaine + iv PCA

Interventions

ropivacaine + iv PCA PROCEDURE

MOTAP catheter with ropivocaine and IV PCA

saline and IV PCA PROCEDURE

MOTAP Catheter with Saline and IV PCA

Eligibility Criteria

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

You may qualify if:

• \>18 years age
• Undergoing liver resection using a subcostal incision

You may not qualify if:

• Patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma)
• Allergy to any study medications
• Patient not able to be extubated postoperatively for any clinical reason
• Laparoscopic surgery
• Co-existing epidural or intrathecal analgesia
• Chronic pain disorders or on long-term opioid use
• History of substance or alcohol abuse
• Transplant donor liver resections
• Patients with liver cirrhosis

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Location

Related Publications (3)

• Page MG, Karanicolas PJ, Cleary S, Wei AC, McHardy P, Ladak SSJ, Ayach N, Sawyer J, McCluskey SA, Srinivas C, Katz J, Coburn N, Hallet J, Law C, Greig P, Clarke H. In-hospital opioid consumption, but not pain intensity scores, predicts 6-month levels of pain catastrophizing following hepatic resection: A trajectory analysis. Eur J Pain. 2019 Mar;23(3):503-514. doi: 10.1002/ejp.1324. Epub 2018 Nov 8.

  PMID: 30298685 DERIVED

• Karanicolas PJ, Cleary S, McHardy P, Kiss A, Sawyer J, Behman R, Ladak S, McCluskey SA, Srinivas C, Katz J, Coburn N, Law C, Wei AC, Greig P, Hallet J, Clarke H. Medial Open Transversus Abdominis Plane (MOTAP) Catheters Reduce Opioid Requirements and Improve Pain Control Following Open Liver Resection: A Multicenter, Blinded, Randomized Controlled Trial. Ann Surg. 2018 Aug;268(2):233-240. doi: 10.1097/SLA.0000000000002657.

  PMID: 29300708 DERIVED

• Karanicolas P, Cleary S, McHardy P, McCluskey S, Sawyer J, Ladak S, Law C, Wei A, Coburn N, Ko R, Katz J, Kiss A, Khan J, Coimbatore S, Lam-McCulloch J, Clarke H. Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:241. doi: 10.1186/1745-6215-15-241.

  PMID: 24950773 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Analgesia, Patient-Controlled; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hance Clarke, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 1, 2017

Record last verified: 2016-05

Locations

CA (2)