Postoperative PainANfiELDNCT07351994
Autonomic Neural Field Block for Visceral Pain in Minimally Invasive Left-Sided Colectomy
An observational study of Postoperative Pain and Postoperative Nausea, run by Antonio Caycedo, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea, Opioid Use
- What is being tested?
- Autonomic Neural Field Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Autonomic Neural Field Block for Visceral Pain Control in Minimally Invasive Left-Sided Colorectal Resections
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.
Read the detailed description
Background and Rationale
Effective postoperative pain control is a cornerstone of enhanced recovery after surgery (ERAS) pathways in colorectal surgery. Adequate analgesia facilitates early mobilization, pulmonary hygiene, gastrointestinal recovery, and timely hospital discharge. Despite widespread adoption of ERAS protocols and multimodal, opioid-sparing analgesic strategies, postoperative pain following left-sided colectomy remains a clinically relevant and persistent challenge. A substantial proportion of patients continue to experience moderate to severe pain in the early postoperative period, which may contribute to increased opioid consumption, postoperative nausea and vomiting (PONV), delayed functional recovery, and prolonged length of stay.
Current perioperative analgesic approaches in colorectal surgery predominantly address somatic pain pathways. These strategies include non-opioid analgesics, opioid-based regimens, local anesthetic infiltration, neuraxial techniques, and transversus abdominis plane (TAP) blocks. While effective in reducing abdominal wall and incisional pain, these modalities do not specifically target visceral postoperative pain, which is mediated through autonomic afferent neural pathways. Visceral pain arises from bowel distension, traction, ischemia, and inflammatory processes affecting the colon and mesentery and is transmitted primarily via sympathetic and parasympathetic fibers. This component of postoperative pain is qualitatively distinct, often diffuse and poorly localized, and frequently associated with nausea, ileus, and other autonomic symptoms.
Neuraxial techniques may provide effective visceral analgesia but are invasive, resource-intensive, and associated with potential adverse effects such as hypotension and urinary retention. As a result, many contemporary ERAS pathways have moved away from routine neuraxial analgesia, creating an unmet need for effective, targeted visceral pain control that is compatible with minimally invasive surgical workflows and ERAS principles.
Targeted modulation of autonomic neural pathways involved in visceral afferent transmission represents a potential strategy to address this gap. The superior hypogastric plexus and inferior mesenteric plexus play central roles in transmitting visceral sensory input from the left colon and rectum and are anatomically consistent structures routinely encountered during left-sided colorectal resection. Intraoperative autonomic neural field block targeting these plexuses may offer a mechanistically distinct approach to perioperative analgesia that complements existing somatic-focused techniques.
Description of the Intervention
The autonomic neural field block is performed intraoperatively during elective minimally invasive (laparoscopic or robotic) left-sided colonic or rectal resection with primary anastomosis constructed above the peritoneal reflection. Following establishment of pneumoperitoneum and trocar placement according to surgeon preference, standard minimally invasive dissection is carried out.
Dissection exposes the inferior mesenteric plexus in proximity to the origin of the inferior mesenteric artery and the superior hypogastric plexus at the level of the sacral promontory. These anatomic landmarks are routinely visualized during left-sided colorectal surgery and do not require additional dissection beyond standard operative technique.
An insulin needle connected to an anesthesia extension set is introduced through a 10-12 mm auxiliary port and attached to a syringe containing a diluted local anesthetic solution. All air is purged from the system prior to injection. Each plexus is infiltrated with approximately 5-7 mL of local anesthetic solution, administered incrementally in 1 mL aliquots. Aspiration is performed prior to each injection to confirm the absence of intravascular placement, and adequate tissue infiltration is confirmed visually. The surgical procedure then proceeds according to standard operative practice. When an extraction incision is used, any remaining local anesthetic solution may be infiltrated into the incision prior to closure.
Perioperative Analgesic Management
The autonomic neural field block is intended to complement, rather than replace, established multimodal perioperative analgesic strategies. Additional analgesic interventions, including TAP blocks, non-opioid medications, and opioid administration, are performed according to institutional ERAS protocols and surgeon or anesthesiologist discretion. This pragmatic approach allows evaluation of autonomic neural blockade within real-world clinical environments and across varying perioperative practices.
Study Design and Registry Framework
This study is a prospective, multicenter observational registry designed to systematically collect perioperative analgesic and recovery outcomes in patients undergoing minimally invasive left-sided colectomy who receive an intraoperative autonomic neural field block. The registry is descriptive and hypothesis-generating and does not mandate a comparator group. Use of additional analgesic modalities, including TAP block, is recorded but not standardized.
Participating centers collect perioperative data using standardized case report forms. Data capture includes patient demographics, operative details, analgesic interventions, and postoperative recovery metrics. The registry is designed to facilitate assessment of feasibility, reproducibility, and variability of outcomes across institutions and practice settings.
Outcome Measures
The primary outcome is postoperative opioid consumption, expressed as morphine milligram equivalents (MME), during the first 24 hours following surgery. Secondary outcomes include cumulative opioid consumption during the first 48 postoperative hours, intraoperative analgesic requirements, incidence of postoperative nausea and vomiting, antiemetic use, length of hospital stay, and readiness for discharge based on ERAS-aligned criteria. Patient-reported pain outcomes are collected during hospitalization and through the first postoperative week after discharge.
Safety and Feasibility
Feasibility outcomes include the ability to perform the autonomic neural field block under direct visualization without deviation from standard operative technique or prolongation of operative time. Adverse events potentially related to the intervention, including bleeding, vascular injury, or hemodynamic instability temporally associated with the block, are recorded. The registry does not alter routine postoperative monitoring or follow-up.
Data Analysis and Future Directions
Data from this registry will be summarized using descriptive statistics. The registry is not powered to assess comparative efficacy but is intended to generate preliminary data regarding analgesic patterns, recovery trajectories, and variability across centers. These findings will inform the design of future comparative or randomized studies, refine patient selection, and help define the role of autonomic neural modulation within ERAS-aligned perioperative pain management strategies for colorectal surgery.
- Conditions
- Postoperative Pain, Postoperative Nausea, Opioid Use
- Being tested
- Autonomic Neural Field Block
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Neural Field BlockProcedure or surgery
Also called Neural blockade
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Autonomic Neural Field Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (5)
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
Measured: 48 hours
Intraoperative opioid administration
Total opioid dose administered intraoperatively, converted to morphine milligram equivalents (MME), as recorded in the anesthesia record.
Measured: Intraoperative period
Postoperative nausea and vomiting (PONV)
Incidence of postoperative nausea and/or vomiting documented during the postoperative period and/or requirement for antiemetic medication.
Measured: First 48 hours after surgery
Antiemetic medication use
Administration of any antiemetic medication during the postoperative period, recorded as a binary outcome and by total number of doses administered.
Measured: First 48 hours after surgery
Postoperative pain intensity
Patient-reported pain intensity measured using a standardized numeric rating scale (0-10) at predefined postoperative time points.
Measured: Postoperative days 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Antonio Caycedo, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Caycedo, MD, Orlando Health, Inc.
- Investigators
- Antonio Caycedo, MD, MSc, Principal investigator, Orlando Health Colon & Rectal Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351994
- Sponsor's protocol ID
- 2365950-1
- Acronym
- ANfiELD
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36050617Caycedo-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.
PubMed 40397141
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Neural Field Block for Visceral Pain Control in Minimally Invasive Left-Sided Colorectal Resections
- ClinicalTrials.gov ID
- NCT07351994
- Acronym / sponsor ID
- ANfiELD / 2365950-1
- Conditions
- Postoperative Pain, Postoperative Nausea, Opioid Use
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Antonio Caycedo, MDUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale
Effective postoperative pain control is a cornerstone of enhanced recovery after surgery (ERAS) pathways in colorectal surgery. Adequate analgesia facilitates early mobilization, pulmonary hygiene, gastrointestinal recovery, and timely hospital discharge. Despite widespread adoption of ERAS protocols and multimodal, opioid-sparing analgesic strategies, postoperative pain following left-sided colectomy remains a clinically relevant and persistent challenge. A substantial proportion of patients continue to experience moderate to severe pain in the early postoperative period, which may contribute to increased opioid consumption, postoperative nausea and vomiting (PONV), delayed functional recovery, and prolonged length of stay.
Current perioperative analgesic approaches in colorectal surgery predominantly address somatic pain pathways. These strategies include non-opioid analgesics, opioid-based regimens, local anesthetic infiltration, neuraxial techniques, and transversus abdominis plane (TAP) blocks. While effective in reducing abdominal wall and incisional pain, these modalities do not specifically target visceral postoperative pain, which is mediated through autonomic afferent neural pathways. Visceral pain arises from bowel distension, traction, ischemia, and inflammatory processes affecting the colon and mesentery and is transmitted primarily via sympathetic and parasympathetic fibers. This component of postoperative pain is qualitatively distinct, often diffuse and poorly localized, and frequently associated with nausea, ileus, and other autonomic symptoms.
Neuraxial techniques may provide effective visceral analgesia but are invasive, resource-intensive, and associated with potential adverse effects such as hypotension and urinary retention. As a result, many contemporary ERAS pathways have moved away from routine neuraxial analgesia, creating an unmet need for effective, targeted visceral pain control that is compatible with minimally invasive surgical workflows and ERAS principles.
Targeted modulation of autonomic neural pathways involved in visceral afferent transmission represents a potential strategy to address this gap. The superior hypogastric plexus and inferior mesenteric plexus play central roles in transmitting visceral sensory input from the left colon and rectum and are anatomically consistent structures routinely encountered during left-sided colorectal resection. Intraoperative autonomic neural field block targeting these plexuses may offer a mechanistically distinct approach to perioperative analgesia that complements existing somatic-focused techniques.
Description of the Intervention
The autonomic neural field block is performed intraoperatively during elective minimally invasive (laparoscopic or robotic) left-sided colonic or rectal resection with primary anastomosis constructed above the peritoneal reflection. Following establishment of pneumoperitoneum and trocar placement according to surgeon preference, standard minimally invasive dissection is carried out.
Dissection exposes the inferior mesenteric plexus in proximity to the origin of the inferior mesenteric artery and the superior hypogastric plexus at the level of the sacral promontory. These anatomic landmarks are routinely visualized during left-sided colorectal surgery and do not require additional dissection beyond standard operative technique.
An insulin needle connected to an anesthesia extension set is introduced through a 10-12 mm auxiliary port and attached to a syringe containing a diluted local anesthetic solution. All air is purged from the system prior to injection. Each plexus is infiltrated with approximately 5-7 mL of local anesthetic solution, administered incrementally in 1 mL aliquots. Aspiration is performed prior to each injection to confirm the absence of intravascular placement, and adequate tissue infiltration is confirmed visually. The surgical procedure then proceeds according to standard operative practice. When an extraction incision is used, any remaining local anesthetic solution may be infiltrated into the incision prior to closure.
Perioperative Analgesic Management
The autonomic neural field block is intended to complement, rather than replace, established multimodal perioperative analgesic strategies. Additional analgesic interventions, including TAP blocks, non-opioid medications, and opioid administration, are performed according to institutional ERAS protocols and surgeon or anesthesiologist discretion. This pragmatic approach allows evaluation of autonomic neural blockade within real-world clinical environments and across varying perioperative practices.
Study Design and Registry Framework
This study is a prospective, multicenter observational registry designed to systematically collect perioperative analgesic and recovery outcomes in patients undergoing minimally invasive left-sided colectomy who receive an intraoperative autonomic neural field block. The registry is descriptive and hypothesis-generating and does not mandate a comparator group. Use of additional analgesic modalities, including TAP block, is recorded but not standardized.
Participating centers collect perioperative data using standardized case report forms. Data capture includes patient demographics, operative details, analgesic interventions, and postoperative recovery metrics. The registry is designed to facilitate assessment of feasibility, reproducibility, and variability of outcomes across institutions and practice settings.
Outcome Measures
The primary outcome is postoperative opioid consumption, expressed as morphine milligram equivalents (MME), during the first 24 hours following surgery. Secondary outcomes include cumulative opioid consumption during the first 48 postoperative hours, intraoperative analgesic requirements, incidence of postoperative nausea and vomiting, antiemetic use, length of hospital stay, and readiness for discharge based on ERAS-aligned criteria. Patient-reported pain outcomes are collected during hospitalization and through the first postoperative week after discharge.
Safety and Feasibility
Feasibility outcomes include the ability to perform the autonomic neural field block under direct visualization without deviation from standard operative technique or prolongation of operative time. Adverse events potentially related to the intervention, including bleeding, vascular injury, or hemodynamic instability temporally associated with the block, are recorded. The registry does not alter routine postoperative monitoring or follow-up.
Data Analysis and Future Directions
Data from this registry will be summarized using descriptive statistics. The registry is not powered to assess comparative efficacy but is intended to generate preliminary data regarding analgesic patterns, recovery trajectories, and variability across centers. These findings will inform the design of future comparative or randomized studies, refine patient selection, and help define the role of autonomic neural modulation within ERAS-aligned perioperative pain management strategies for colorectal surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autonomic Neural Field Block Cohort | – | Procedure: Autonomic Neural Field BlockThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomic Neural Field BlockAlso: Neural blockadeAn 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. | Procedure or surgery | Autonomic Neural Field Block Cohort |
Primary outcome
Opiod consumption
Time frame: 24 hours
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.
5 secondary outcomes
Postoperative opioid consumption (48 hours)
Time frame: 48 hours
Intraoperative opioid administration
Time frame: Intraoperative period
Postoperative nausea and vomiting (PONV)
Time frame: First 48 hours after surgery
Antiemetic medication use
Time frame: First 48 hours after surgery
Postoperative pain intensity
Time frame: Postoperative days 0-7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 36050617Daes 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.
- Results publication: PubMed 40397141Caycedo-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Caycedo, MD, MSc principal investigator
Orlando Health Colon & Rectal Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postoperative Nausea, run by Antonio Caycedo, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caycedo, MD. MSc (3218433864, antonio.caycedo@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiod consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07351994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.