Autonomic Neural Field Block for Visceral Pain in Minimally Invasive Left-Sided Colectomy

NCT07351994 | Not Yet Recruiting

• 1 other identifier: 2365950-1
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Postoperative Nausea; Opioid Use

Outcome Measures

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.

  24 hours

Secondary Outcomes (5)

• Postoperative opioid consumption (48 hours)

  48 hours

• Intraoperative opioid administration

  Intraoperative period

• Postoperative nausea and vomiting (PONV)

  First 48 hours after surgery

• Antiemetic medication use

  First 48 hours after surgery

• Postoperative pain intensity

  Postoperative days 0-7

Study Arms (1)

Autonomic Neural Field Block Cohort

This cohort includes adult patients undergoing elective minimally invasive (laparoscopic or robotic) left-sided colonic or rectal resection with primary anastomosis who receive an intraoperative autonomic neural field block targeting the superior hypogastric and inferior mesenteric plexuses. The autonomic neural field block is performed under direct visualization as an adjunct to standard perioperative care within established enhanced recovery after surgery (ERAS) pathways. Use of additional analgesic modalities, including transversus abdominis plane blocks, non-opioid analgesics, and opioids, is permitted according to institutional practice and is recorded as part of routine perioperative management.

Procedure: Autonomic Neural Field Block

Interventions

Autonomic Neural Field Block PROCEDURE

An 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.

Also known as: Neural blockade

Autonomic Neural Field Block Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antonio Caycedo, MD: lead

Related Publications (2)

• Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.

  PMID: 36050617 BACKGROUND

• Caycedo-Marulanda A, Sanchez A, Ferrara M, Daes J. Intraoperative autonomic field block combined with the transversus abdominis plane block: for left-sided colectomies (video forum). Tech Coloproctol. 2025 May 21;29(1):117. doi: 10.1007/s10151-025-03154-y. No abstract available.

  PMID: 40397141 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Antonio Caycedo, MD, MSc

  Orlando Health Colon & Rectal Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caycedo, MD. MSc

CONTACT

3218433864; antonio.caycedo@orlandohealth.com

Broome

CONTACT

3218433864; barbara.broome@orlandohealth.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Colorectal Surgery

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 20, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: at 3,6 moths and after final results prior to any publication submission
• Access Criteria: Reasonable request