Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07351994
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Scheduled for elective minimally invasive (laparoscopic or robotic) left-sided colonic or rectal resection with primary anastomosis constructed above the peritoneal reflection (e.g., sigmoid colectomy, left colectomy, anterior resection/rectosigmoid resection with intraperitoneal anastomosis).
* Planned intraoperative administration of autonomic neural field block targeting the superior hypogastric plexus and/or inferior mesenteric plexus, performed under direct visualization, as part of routine operative workflow.
* Managed perioperatively under an institutional standard analgesic pathway (e.g., ERAS or equivalent), with postoperative opioid administration recorded in the medical record.
* Ability to provide informed consent
Exclusion Criteria:
* Emergency/urgent colorectal surgery (e.g., perforation, uncontrolled bleeding, toxic megacolon, obstructing cancer requiring urgent operation).
* Planned open left-sided colectomy/rectal resection (minimally invasive approach not intended).
* Procedures in which no primary anastomosis is created (e.g., Hartmann's procedure, end colostomy, permanent diversion without anastomosis).
* Planned low pelvic/extra-peritoneal anastomosis (e.g., low anterior resection with anastomosis at or below the peritoneal reflection) or planned handsewn coloanal anastomosis.
* Known allergy or contraindication to the local anesthetic agents used for the block (or inability to receive local anesthetic for clinical reasons).
* Inability to reliably capture outcome data for the primary endpoint (e.g., anticipated transfer to another facility within 24 hours post-op, incomplete medication administration records).
* Pregnancy
* Prisoners or other protected populations where participation is restricted
* Chronic opioid therapy at baseline defined as daily opioid use for \> 30 days preoperatively, or baseline opioid dose \> 30 MME/day
* Planned use of neuraxial analgesia (epidural/spinal) intended for postoperative analgesia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07351994
Study Brief:
Protocol Section:
NCT07351994