Autonomic Neural Field Block for Visceral Pain in Minimally Invasive Left-Sided Colectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAntonio Caycedo, MD
About this trial
Effective postoperative pain control is a core component of enhanced recovery after surgery (ERAS) pathways in colorectal surgery; however, postoperative pain following minimally invasive left-sided colectomy remains a persistent clinical challenge. Standard multimodal analgesic strategies primarily target somatic pain pathways and may inadequately address visceral postoperative pain, which is mediated through autonomic afferent neural pathways. Residual visceral pain is associated with increased opioid consumption, postoperative nausea and vomiting, delayed recovery, and prolonged length of stay.
This prospective, multicenter observational registry evaluates the feasibility and real-world outcomes of an intraoperative autonomic neural field block targeting the superior hypogastric and inferior mesenteric plexuses during minimally invasive left-sided colectomy. The technique is performed under direct visualization as an adjunct to standard ERAS-based analgesic care. The primary outcome is postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include opioid use through 48 hours, postoperative nausea and vomiting, antiemetic use, pain scores, length of stay, and readiness for discharge. Data from this registry will inform future comparative studies and help define the role of autonomic neural modulation in perioperative pain management for colorectal surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population includes adult patients undergoing elective minimally invasive (laparoscopic or robotic) left-sided colonic or rectal resection with primary anastomosis constructed above the peritoneal reflection. Eligible patients receive an intraoperative autonomic neural field block targeting the superior hypogastric and/or inferior mesenteric plexuses under direct visualization as part of routine operative care. Perioperative management follows institutional standardized analgesic pathways, such as enhanced recovery after surgery (ERAS) protocols, with postoperative opioid administration documented in the medical record. Patients undergoing emergency surgery, procedures without primary anastomosis, low pelvic or extraperitoneal anastomoses, planned open surgery, or those with contraindications to local anesthetics are excluded.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Autonomic Neural Field Block
Procedure/SurgeryAn intraoperative autonomic neural field block targeting the superior hypogastric and inferior mesenteric plexuses is performed under direct visualization during elective minimally invasive left-sided colorectal resection. The block is administered using incremental injections of diluted local anesthetic as an adjunct to standard perioperative analgesic care within established enhanced recovery after surgery (ERAS) pathways.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Autonomic Neural Field Block Cohort1 intervention
Trial outcomes
Primary outcomes
1
Opiod consumption
Total opioid consumption during the first 24 hours following surgery, converted to morphine milligram equivalents (MME), based on all opioid medications administered during the postoperative period.
Time frame
24 hoursSecondary outcomes
1
Postoperative opioid consumption (48 hours)
Total cumulative opioid consumption during the first 48 hours following surgery, converted to morphine milligram equivalents (MME), based on all opioid medications administered postoperatively
Time frame
48 hours2
Intraoperative opioid administration
Total opioid dose administered intraoperatively, converted to morphine milligram equivalents (MME), as recorded in the anesthesia record.
Time frame
Intraoperative period3
Postoperative nausea and vomiting (PONV)
Incidence of postoperative nausea and/or vomiting documented during the postoperative period and/or requirement for antiemetic medication.
Time frame
First 48 hours after surgery4
Antiemetic medication use
Administration of any antiemetic medication during the postoperative period, recorded as a binary outcome and by total number of doses administered.
Time frame
First 48 hours after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Antonio Caycedo, MD
Lead sponsor
Orlando Health, Inc.
Sponsor institution
Source ClinicalTrials.gov
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