Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Disorders
- Sponsor
- Kyungpook National University Hospital
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Pain numerical rating scale (NRS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Detailed Description
In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics. The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Investigators
Soo Yeun Park
Colorectal Cancer Center, Kyungpook National University Chilgok Hospital
Kyungpook National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 18-80 years, either sex
- •Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
- •Willingness and ability to sign an informed consent document
Exclusion Criteria
- •Allergies to anesthetic or analgesic medications
- •Contraindication to the use of locoregional anesthesia
- •Chronic opioid use
- •Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
- •Necessity of major resection other than colorectal, palliative surgery
- •BMI above 35 kg/m2
- •American Society of Anesthesiologists (ASA) physical status above 3
Outcomes
Primary Outcomes
Pain numerical rating scale (NRS)
Time Frame: within the first 6 hours after surgery
1. Pain NRS during rest and cough 2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
Secondary Outcomes
- Pain NRS(12, 24, 36, 48, 72 hour after surgery)
- Rescue opioid analgesic requirement(postoperative day 0, 1, 2, 3)
- Postoperative nausea and vomiting scale(12, 24, 36, 48, 72 hour after surgery)
- Time to first oral fluid intake(8 weeks after surgery)
- Occurrence of prolonged post-operative ileus(8 weeks after surgery)
- Time to first oral soft diet(8 weeks after surgery)
- Length of hospital stay(8 weeks after surgery)