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

Primary Purpose

Pain, Postoperative, Pain, Abdominal, Analgesia

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Active drug
Placebo
Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block
Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
Injection of placebo - Ultrasound-guided transverse abdominal plane block
Injection of placebo - Laparoscopic assisted transverse abdominal plane block
Sponsored by
Claus Anders Bertelsen, PhD, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sydvestjysk SygehusRecruiting
  • Regionshospitalet HerningRecruiting
  • Copenhagen University Hospital - North ZealandRecruiting
  • Copenhagen University Hospital - Hvidovre
  • Regionshospitalet ViborgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ultrasound-guided TAP

Laparoscopic assisted TAP

Placebo

Arm Description

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

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

Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Outcomes

Primary Outcome Measures

Total morphine dose equivalents administered.
Intravenously in milligrams.

Secondary Outcome Measures

Total morphine dose equivalents administered in the operation theater.
Intravenously in milligrams.
Total morphine dose equivalents administered in the post anesthesia care unit.
Intravenously in milligrams.
Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1.
11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).
Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1
11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)
Postoperative length of stay.
Days - Measured from the end of anesthesia.
Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1.
4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).
Total dose of antiemetic medication administered.
Intravenously in milligrams.
Total dose of antiemetic medication administered in the operating theater.
Intravenously in milligrams.
Time spent in the post anesthesia care unit.
From the end of anesthesia to discharge to ward. Measured in hours and minutes.
Postoperative mobilisation.
4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).
Quality of Recovery 15.
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 complications.
According to the Clavien-Dindo classification of surgical complications.
Need for rescue TAP-block or epidural analgesia.
Epidural or TAP-block administered post surgery.

Full Information

First Posted
March 9, 2020
Last Updated
October 2, 2023
Sponsor
Claus Anders Bertelsen, PhD, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04311099
Brief Title
Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery
Acronym
OPMICS
Official Title
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Claus Anders Bertelsen, PhD, MD

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Abdominal, Analgesia, Surgery, Colon Cancer, Injection Site

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided TAP
Arm Type
Experimental
Arm Description
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
Arm Title
Laparoscopic assisted TAP
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery
Intervention Type
Drug
Intervention Name(s)
Active drug
Other Intervention Name(s)
Ropivacaine
Intervention Description
Injection of Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline solution
Intervention Description
Injection of Saline solution
Intervention Type
Procedure
Intervention Name(s)
Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block
Intervention Description
Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Intervention Type
Procedure
Intervention Name(s)
Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
Intervention Description
Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Intervention Type
Procedure
Intervention Name(s)
Injection of placebo - Ultrasound-guided transverse abdominal plane block
Intervention Description
Lateral ultrasound-guided transverse abdominal plane block with saline solution
Intervention Type
Procedure
Intervention Name(s)
Injection of placebo - Laparoscopic assisted transverse abdominal plane block
Intervention Description
Laparoscopic assisted subcostal transverse abdominal plane block with saline solution
Primary Outcome Measure Information:
Title
Total morphine dose equivalents administered.
Description
Intravenously in milligrams.
Time Frame
The first 24 hours from the end of anesthesia.
Secondary Outcome Measure Information:
Title
Total morphine dose equivalents administered in the operation theater.
Description
Intravenously in milligrams.
Time Frame
Up to 12 hours.
Title
Total morphine dose equivalents administered in the post anesthesia care unit.
Description
Intravenously in milligrams.
Time Frame
The first 24 hours from the end of anesthesia.
Title
Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1.
Description
11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).
Time Frame
Postoperative Day 1.
Title
Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1
Description
11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)
Time Frame
Postoperative Day 1.
Title
Postoperative length of stay.
Description
Days - Measured from the end of anesthesia.
Time Frame
Up to 30 days.
Title
Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1.
Description
4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).
Time Frame
Postoperative Day 1.
Title
Total dose of antiemetic medication administered.
Description
Intravenously in milligrams.
Time Frame
In the first 24 hours from the end of anesthesia.
Title
Total dose of antiemetic medication administered in the operating theater.
Description
Intravenously in milligrams.
Time Frame
Up to 12 hours.
Title
Time spent in the post anesthesia care unit.
Description
From the end of anesthesia to discharge to ward. Measured in hours and minutes.
Time Frame
Up to 30 hours.
Title
Postoperative mobilisation.
Description
4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).
Time Frame
Postoperative Day 1.
Title
Quality of Recovery 15.
Description
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.
Time Frame
Postoperative Day 1.
Title
Postoperative complications.
Description
According to the Clavien-Dindo classification of surgical complications.
Time Frame
Postoperative Day 30.
Title
Need for rescue TAP-block or epidural analgesia.
Description
Epidural or TAP-block administered post surgery.
Time Frame
Postoperative Day 30.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claus A Bertelsen, PhD
Phone
+4551906303
Email
cabertelsen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher B Salmonsen, MD
Phone
+4523373025
Email
chrisbsal@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus A Bertelsen, PhD
Organizational Affiliation
Copenhagen University Hospital - North Zealand
Official's Role
Study Chair
Facility Information:
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor J Verwall, PhD
Facility Name
Regionshospitalet Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders H Madsen, PhD
Facility Name
Copenhagen University Hospital - North Zealand
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher B Salmonsen, MD
Email
christopher.blom.salmonsen@region.dk
Facility Name
Copenhagen University Hospital - Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Terminated
Facility Name
Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uffe S Løwe, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Links:
URL
https://www.dsth.dk/bridging2018/
Description
Pausing or bridging patients in antithrombotic therapy, which should undergo an operative intervention.

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Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

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