Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery (OPMICS)

October 2, 2023 updated by: Claus Anders Bertelsen, PhD, MD

Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial

The purpose of the trial is to identify the "most simple non-inferior of three different methods", placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound guided TAP block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and length of stay (LOS) will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introducing laparoscopy in colorectal surgery and optimizing the postoperative care using the standardized protocols of enhanced recovery after surgery (ERAS) have significantly improved patient outcomes and LOS. Better pain management has the potential to further improve these outcomes. Since the introduction of ultrasound-guided abdominal wall blocks, much research has been done in that field, but no consensus has been reached concerning the optimal block technique; where to and when to inject the block, or which drug to use. Newly published randomized controlled trials show interesting results regarding the L-TAP which has several advantages to the US-TAP, including the ease of performance, less dependency on specialized skills or equipment and avoidance of intraperitoneal infiltration. but these results need to be solidified with multicentre trials. Besides optimizing postoperative pain management, better block techniques could potentially decrease LOS in patients after minimally invasive colorectal surgery.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Sydvestjysk Sygehus
        • Contact:
          • Victor J Verwall, PhD
      • Herning, Denmark, 7400
        • Recruiting
        • Regionshospitalet Herning
        • Contact:
          • Anders H Madsen, PhD
      • Hillerød, Denmark, 3400
      • Hvidovre, Denmark, 2650
        • Terminated
        • Copenhagen University Hospital - Hvidovre
      • Viborg, Denmark, 8800
        • Recruiting
        • Regionshospitalet Viborg
        • Contact:
          • Uffe S Løwe, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients planned to receive curative elective minimally invasive colon surgery for colon cancer or adenoma without a planned ostomy. Colon cancer or adenoma is defined by a distance of more than 15 cm from the anal verge to the distal limitation of the tumour or adenoma as measured by rigid sigmoidoscope. The following procedural codes are included:
  • Laparoscopic ileocecal resection
  • Laparoscopic right hemicolectomy
  • Other laparoscopic resection of both small and large bowel
  • Laparoscopic resection of transverse colon
  • Laparoscopic left hemicolectomy
  • Laparoscopic resection of sigmoid colon
  • Other laparoscopic colon resection
  • Having given informed written consent.

Exclusion Criteria:

  • Known allergy to local analgesics
  • Known liver failure Class C according to the Child-Pugh Score
  • Body weight of less than 40 kg
  • History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic)
  • Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia
  • Predictably non-compliant due to language barrier or psychiatric disease
  • Patients rescheduled for open surgery, before the intervention has been administered
  • Patients where the indication for surgery changes before the intervention has been administered
  • Patients with known inflammatory bowel disease
  • Patients who have previously undergone open major abdominal surgery defined by prior intraabdominal surgery with a midline or upper abdominal incision of more than 8 cm
  • Incisional hernia
  • Patients with a history of abdominal wall surgery including resection of the external oblique muscles, the internal oblique muscles, the transversus abdominis muscles, the rectus abdominis muscles or their fascial components
  • Pregnancy (patients are screened using urine human chorionic gonadotropin upon admission if female and not postmenopausal).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided TAP
Ultrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery
Drug: Active drug
Injection of Ropivacaine
Other Names:
  • Ropivacaine
Drug: Placebo
Injection of Saline solution
Other Names:
  • Saline solution
Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block
Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block
Laparoscopic assisted subcostal transverse abdominal plane block with saline solution
Experimental: Laparoscopic assisted TAP
Laparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery
Drug: Active drug
Injection of Ropivacaine
Other Names:
  • Ropivacaine
Drug: Placebo
Injection of Saline solution
Other Names:
  • Saline solution
Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block
Lateral ultrasound-guided transverse abdominal plane block with saline solution
Placebo Comparator: Placebo
Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery
Drug: Placebo
Injection of Saline solution
Other Names:
  • Saline solution
Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block
Laparoscopic assisted subcostal transverse abdominal plane block with saline solution
Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block
Lateral ultrasound-guided transverse abdominal plane block with saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine dose equivalents administered.
Time Frame: The first 24 hours from the end of anesthesia.
Intravenously in milligrams.
The first 24 hours from the end of anesthesia.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine dose equivalents administered in the operation theater.
Time Frame: Up to 12 hours.
Intravenously in milligrams.
Up to 12 hours.
Total morphine dose equivalents administered in the post anesthesia care unit.
Time Frame: The first 24 hours from the end of anesthesia.
Intravenously in milligrams.
The first 24 hours from the end of anesthesia.
Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1.
Time Frame: Postoperative Day 1.
11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).
Postoperative Day 1.
Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1
Time Frame: Postoperative Day 1.
11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)
Postoperative Day 1.
Postoperative length of stay.
Time Frame: Up to 30 days.
Days - Measured from the end of anesthesia.
Up to 30 days.
Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1.
Time Frame: Postoperative Day 1.
4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).
Postoperative Day 1.
Total dose of antiemetic medication administered.
Time Frame: In the first 24 hours from the end of anesthesia.
Intravenously in milligrams.
In the first 24 hours from the end of anesthesia.
Total dose of antiemetic medication administered in the operating theater.
Time Frame: Up to 12 hours.
Intravenously in milligrams.
Up to 12 hours.
Time spent in the post anesthesia care unit.
Time Frame: Up to 30 hours.
From the end of anesthesia to discharge to ward. Measured in hours and minutes.
Up to 30 hours.
Postoperative mobilisation.
Time Frame: Postoperative Day 1.
4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).
Postoperative Day 1.
Quality of Recovery 15.
Time Frame: Postoperative Day 1.
The Quality of Recovery 15 is a 15-item questionnaire that measures the patient's quality of recovery. Each item is answered on an 11-point Numerical Rating Scale. The score ranges from 0 to 150 with a higher score indicating a better quality of recovery. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state.
Postoperative Day 1.
Postoperative complications.
Time Frame: Postoperative Day 30.
According to the Clavien-Dindo classification of surgical complications.
Postoperative Day 30.
Need for rescue TAP-block or epidural analgesia.
Time Frame: Postoperative Day 30.
Epidural or TAP-block administered post surgery.
Postoperative Day 30.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claus Anders Bertelsen, PhD, MD

Investigators

  • Study Chair: Claus A Bertelsen, PhD, Copenhagen University Hospital - North Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPMICS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses. Proposals should be directed to Claus A Bertelsen (cabertelsen@gmail.com). A Data Processing Agreement according to the EU General Data Protection Regulation has to be signed before data sharing.

IPD Sharing Time Frame

For 15 years after publication

IPD Sharing Access Criteria

A methodologically sound proposal for meta-analyses

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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