Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery
- Conditions
- SurgeryInjection SitePain, AbdominalColon CancerPain, PostoperativeAnalgesia
- Interventions
- Drug: Active drugDrug: PlaceboProcedure: Injection of placebo - Ultrasound-guided transverse abdominal plane blockProcedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane blockProcedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane blockProcedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block
- Registration Number
- NCT04311099
- Lead Sponsor
- Claus Anders Bertelsen, PhD, MD
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 360
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic assisted TAP Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block 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 Ultrasound-guided TAP Placebo 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 Ultrasound-guided TAP Active drug 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 Active drug 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 Placebo 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 Ultrasound-guided TAP Injection of placebo - Laparoscopic assisted transverse abdominal plane block 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 Placebo Injection of placebo - Ultrasound-guided transverse abdominal plane block Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery Placebo Injection of placebo - Laparoscopic assisted transverse abdominal plane block Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery Laparoscopic assisted TAP Placebo 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 Ultrasound-guided TAP Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block 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 Injection of placebo - Ultrasound-guided transverse abdominal plane block 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
- Primary Outcome Measures
Name Time Method Total morphine dose equivalents administered. The first 24 hours from the end of anesthesia. Intravenously in milligrams.
- Secondary Outcome Measures
Name Time Method Total morphine dose equivalents administered in the operation theater. Up to 12 hours. Intravenously in milligrams.
Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1 Postoperative Day 1. 11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)
Need for rescue TAP-block or epidural analgesia. Postoperative Day 30. Epidural or TAP-block administered post surgery.
Total dose of antiemetic medication administered. In the first 24 hours from the end of anesthesia. Intravenously in milligrams.
Total morphine dose equivalents administered in the post anesthesia care unit. The first 24 hours from the end of anesthesia. Intravenously in milligrams.
Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1. Postoperative Day 1. 11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).
Postoperative length of stay. Up to 30 days. Days - Measured from the end of anesthesia.
Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1. Postoperative Day 1. 4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).
Quality of Recovery 15. 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.
Total dose of antiemetic medication administered in the operating theater. Up to 12 hours. Intravenously in milligrams.
Time spent in the post anesthesia care unit. Up to 30 hours. From the end of anesthesia to discharge to ward. Measured in hours and minutes.
Postoperative mobilisation. Postoperative Day 1. 4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).
Postoperative complications. Postoperative Day 30. According to the Clavien-Dindo classification of surgical complications.
Trial Locations
- Locations (5)
Copenhagen University Hospital - Hvidovre
🇩🇰Hvidovre, Denmark
Sydvestjysk Sygehus
🇩🇰Esbjerg, Denmark
Regionshospitalet Herning
🇩🇰Herning, Denmark
Copenhagen University Hospital - North Zealand
🇩🇰Hillerød, Denmark
Regionshospitalet Viborg
🇩🇰Viborg, Denmark