Comparing laparoscopic TAP block and epidural analgesia for post-operative pain relief
Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial
This study is testing whether a new pain relief method called laparoscopic TAP block works better than traditional epidural analgesia for patients recovering from laparoscopic colon surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT05214261 on ClinicalTrials.gov |
What this trial studies
The LAPTAP trial aims to evaluate the effectiveness of laparoscopic-guided TAP block versus epidural analgesia for managing post-operative pain in patients undergoing elective laparoscopic colon surgery. This study will involve administering the TAP block by surgeons using laparoscopic visual guidance, a method that has not been extensively compared to traditional epidural analgesia. By assessing safety and efficiency, the trial seeks to provide valuable insights into optimal pain management strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing elective laparoscopic colorectal surgery for conditions such as colorectal neoplasia or diverticulitis.
Not a fit: Patients with contraindications to epidural or TAP block placement, such as allergies to anesthetics or those requiring urgent surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for patients undergoing laparoscopic colon surgery.
How similar studies have performed: While there have been studies on TAP blocks and epidural analgesia separately, this specific comparison using laparoscopic guidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
IInclusion criteria * Patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area * Patients able to provide informed written consent * Patients capable of completing questionnaires at the time of consent Exclusion criteria * Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone * Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal) * Urgent or emergent surgery precluding epidural catheter placement or TAP block * Systemic Infection contraindicating epidural catheter placement or TAP block * Rectal surgery * Pregnant or suspected pregnancy * Age \< 18 years * Planned open surgery * Planned bowel stoma (protective diversion and/or permanent stoma) * Unwillingness to participate in follow-up assessments * Patients with severe chronic pain * Known sensibility for opioid side effects * i.v.-PCA is contraindicated (for example drug abuse) * No informed consent
Where this trial is running
Oulu
- Surgery and Intensive Care Research Unit — Oulu, Finland (Recruiting)
Study contacts
- Principal investigator: Heikki Huhta, PhD — Oulu University Hospital
- Study coordinator: Heikki Huhta, PhD
- Email: heikki.huhta@ppshp.fi
- Phone: +3583152011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.