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

August 4, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Sydvestjysk Sygehus
      • Herning, Denmark, 7400
        • Regionshospitalet Herning
      • Hillerød, Denmark, 3400
        • Copenhagen University Hospital - North Zealand
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital - Hvidovre
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Claus Anders Bertelsen, PhD, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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