Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative, Pain, Abdominal, Analgesia, Surgery, Colon Cancer, Injection Site

Intervention / Treatment
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* Drug: Active drug
* Drug: Placebo
* Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block
* Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
* Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block
* Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-guided TAP<br>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<br>* Injection of Ropivacaine<br>* Other names: Ropivacaine;Drug: Placebo<br>* Injection of Saline solution<br>* Other names: Saline solution;Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block<br>* Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml<br>Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block<br>* Laparoscopic assisted subcostal transverse abdominal plane block with saline solution<br>|
| Experimental: Laparoscopic assisted TAP<br>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<br>* Injection of Ropivacaine<br>* Other names: Ropivacaine;Drug: Placebo<br>* Injection of Saline solution<br>* Other names: Saline solution;Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block<br>* Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml<br>Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block<br>* Lateral ultrasound-guided transverse abdominal plane block with saline solution<br>|
| Placebo Comparator: Placebo<br>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<br>* Injection of Saline solution<br>* Other names: Saline solution;Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block<br>* Lateral ultrasound-guided transverse abdominal plane block with saline solution<br>Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block<br>* Laparoscopic assisted subcostal transverse abdominal plane block with saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine dose equivalents administered. | 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. | Intravenously in milligrams. | Up to 12 hours. | 
| Total morphine dose equivalents administered in the post anesthesia care unit. | 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. | 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 | 11-point Numeric Rating Scale. 0-10 (higher score means worse outcome) | Postoperative Day 1. | 
| Postoperative length of stay. | 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. | 4-point Numeric Rating Scale. 0-3 (higher score means worse outcome). | Postoperative Day 1. | 
| Total dose of antiemetic medication administered. | Intravenously in milligrams. | In the first 24 hours from the end of anesthesia. | 
| Total dose of antiemetic medication administered in the operating theater. | Intravenously in milligrams. | Up to 12 hours. | 
| Time spent in the post anesthesia care unit. | From the end of anesthesia to discharge to ward. Measured in hours and minutes. | Up to 30 hours. | 
| Postoperative mobilisation. | 4-point Verbal Rating Scale. 1-4 (higher score means worse outcome). | Postoperative Day 1. | 
| 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 Day 1. | 
| Postoperative complications. | According to the Clavien-Dindo classification of surgical complications. | Postoperative Day 30. | 
| Need for rescue TAP-block or epidural analgesia. | Epidural or TAP-block administered post surgery. | Postoperative Day 30. |