Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP) (BAPTAP)

Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP): A Randomized, Controlled, Double-Blind Trial

Effective postoperative pain management is essential for enhanced recovery after laparoscopic colorectal surgery. This randomized, controlled, double-blind trial will compare conventional postoperative analgesia (intravenous medications plus surgical wound infiltration) with a locoregional strategy combining a peripheral autonomic block (inferior mesenteric and superior hypogastric plexuses) and a transversus abdominis plane (TAP) block. We hypothesize that the combined strategy (BAPTAP) reduces pain intensity and opioid consumption in the first 48 hours after Left-Sided Colorectal Resection.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Pain Management; Colorectal Surgery; Anesthesia; Post Operative Analgesia; Transversus Abdominis Plane (TAP) Block; Autonomic Nerve Block
• Intervention / Treatment: Procedure: Minimally Invasive Left-Sided Colorectal Resection; Procedure: BAPTAP (Peripheral Autonomic Blockade + TAP Block); Procedure: Trocar/Incision Infiltration

Detailed Description

Postoperative pain after colorectal surgery involves both somatic and visceral components. Abdominal wall blocks target somatic nociception, whereas visceral pain often requires different approaches. Autonomic plexus blocks have shown promise in gynecologic and bariatric surgery. This study will randomize 140 adults undergoing elective laparoscopic Left-Sided Colorectal Resection to either: (1) BAPTAP (peripheral autonomic plexus block targeting the superior hypogastric and inferior mesenteric plexuses plus bilateral ultrasound-guided TAP block) in addition to standardized multimodal analgesia; or (2) Control (standardized multimodal analgesia and trocar/wound infiltration alone). Primary outcomes are pain intensity (Numerical Rating Scale) at predefined time points and cumulative opioid consumption (IV morphine equivalents) in the first 48 hours. Secondary outcomes include functional recovery milestones, adverse events, complications related to blocks or systemic analgesia, patient satisfaction, and quality of recovery via the PAIN OUT questionnaire. Randomization is computer-generated (1:1). Participants, postoperative care teams, and outcome assessors will be blinded; the anesthesiologist performing the block will not participate in postoperative assessments.

This is an interventional, randomized (1:1), parallel-assignment, double-masked clinical trial with an estimated enrollment of 140 participants, designed for supportive care (postoperative analgesia) in patients undergoing minimally invasive left-sided colorectal surgery for indications including colorectal neoplasms and diverticular disease, with outcomes focused on postoperative pain. Participants aged 18-80 years of any sex, ASA I-II, scheduled for elective laparoscopic Left-Sided Colorectal Resection at a single institution and able to understand and sign informed consent are eligible. Exclusions include known allergy to study medications (Ropivacaine), coagulation disorders, pregnancy, inability to provide consent, chronic pain on opioid therapy, and BMI > 35 kg/m². Two arms will be compared: the experimental arm receives a peripheral autonomic plexus block (targeting the superior hypogastric and inferior mesenteric plexuses) with ropivacaine 0.2% at 8 mL per site performed laparoscopically before dissection plus a bilateral ultrasound-guided TAP block with ropivacaine 0.33% at 30 mL per side, in addition to standard multimodal analgesia; the active comparator arm receives the same multimodal analgesia with trocar/wound infiltration using ropivacaine 0.33% up to 60 mL total, without autonomic plexus or TAP blocks. Masking is double (participant and outcomes assessor); the anesthesiologist who performs the block is unblinded and does not take part in postoperative care or assessments, while participants, and assessors remain blinded. The coprimary outcomes are pain intensity at rest on an NRS 0-10 at 2, 6, 12, 24, and 48 hours after surgery and cumulative opioid consumption over the first 48 hours expressed as intravenous morphine equivalents calculated as (fentanyl mg × 100) + (morphine IV mg) plus, if applicable, (tramadol mg ÷ 10); secondary outcomes include time to return of bowel function (first flatus and first bowel movement) through discharge, time to ambulation up to 48 hours, length of hospital stay during the index admission, adverse events and complications related to the TAP/autonomic blocks or systemic analgesia from the intraoperative period to 30 days postoperatively, patient-reported outcomes at 48 hours using PAIN OUT (Portuguese-validated IPO) covering pain frequency, interference with activities and mood, satisfaction, and participation, and overall patient satisfaction with pain management at 48 hours; an exploratory outcome consists of a 5-10 minute qualitative interview at 48 hours addressing expectations, trust, coping, and emotional impact.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MATHEUS MMMDE MEYER, MD; Phone Number: 5531988044987; Email: matheusww@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150221
      • Recruiting
      • Santa Casa de Misericórdia de Belo Horizonte
      • Contact: Matheus MMM Meyer, MD; Phone Number: 5531988044987; Email: drmatheusmeyer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective laparoscopic left-sided colorectal resection
• ASA physical status I-II
• Ability to understand the study and sign informed consent

Exclusion Criteria:

• Known allergy to study medications (e.g., local anesthetics)
• Coagulation disorders
• Pregnancy
• Inability to understand or provide consent
• Chronic pain on opioid therapy
• BMI > 35 kg/m²

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block); General anesthesia and Peripheral autonomic plexus block (superior hypogastric and inferior mesenteric plexuses) with ropivacaine 0.2%, 8 mL per site; performed laparoscopically prior to dissection, associated with Bilateral ultrasound-guided TAP block using ropivacaine 0.33%, 30 mL per side.	Procedure: Minimally Invasive Left-Sided Colorectal Resection; Elective laparoscopic anterior/rectosigmoid resection or sigmoid colectomy per institutional standards; not randomized.; Procedure: BAPTAP (Peripheral Autonomic Blockade + TAP Block); General anesthesia combined with peripheral autonomic plexus blockade (superior hypogastric and inferior mesenteric plexuses) using 0.2% ropivacaine, 8 mL per site; performed laparoscopically prior to dissection, in association with bilateral ultrasound-guided TAP block with 0.33% ropivacaine, 30 mL per side.
Active Comparator: Arm B - Control: Trocar/wound infiltration (Standard of Care); General anesthesia and trocar/wound infiltration - ropivacaine 0.33% up to 60 mL total.	Procedure: Minimally Invasive Left-Sided Colorectal Resection; Elective laparoscopic anterior/rectosigmoid resection or sigmoid colectomy per institutional standards; not randomized.; Procedure: Trocar/Incision Infiltration; General anesthesia with trocar/incision infiltration using 0.33% ropivacaine, up to a total volume of 60 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity at rest (NRS 0-10); Time Frame: 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively; Higher scores indicate worse pain.	Day 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperatively
Cumulative opioid consumption	Cumulative opioid consumption (IV morphine equivalents, mg) in the first 48 hours; Time Frame: baseline to 48 hours; Calculated as: (Fentanyl mg × 100) + (Morphine IV mg) [+ (Tramadol mg ÷ 10) if applicable].	Day 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperatively
Pain frequency - Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO)	Pain frequency is assessed by evaluating both intensity and temporal occurrence of postoperative pain. Patients are asked to report: The worst pain intensity experienced since surgery, measured on an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable). The least pain intensity experienced during the same period, using the same scale. The frequency of severe pain, expressed as the estimated percentage of time the patient experienced severe pain since surgery, ranging from 0% (never) to 100% (always). This domain captures not only peak pain intensity but also pain variability and persistence over time.	Day 2 - 48 hours postoperatively
Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO) - interference with activities and mood	This domain evaluates the functional and emotional impact of postoperative pain. Interference with physical activities is assessed using an 11-point NRS (0 = did not interfere; 10 = completely interfered) in relation to: Activities in bed (e.g., turning, sitting up, changing position); Deep breathing or coughing; Sleep quality; Activities out of bed (e.g., walking, standing, sitting in a chair), when applicable Interference with mood and emotional well-being is evaluated by assessing the extent to which pain caused the patient to feel: Anxious; Helpless Each emotional parameter is rated on an 11-point NRS from 0 (not at all) to 10 (extremely), reflecting the psychological burden associated with postoperative pain.	Day 2 - 48 hours postoperatively
Participation - Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO)	Participation assesses the patient's involvement in pain management decisions and information exchange. It includes: The degree to which the patient felt allowed to participate in decisions regarding pain treatment, rated on an 11-point NRS from 0 (not at all) to 10 (very much so). Whether the patient received information about available pain treatment options (yes/no). Whether the patient would have preferred more pain treatment than was provided (yes/no). This domain emphasizes shared decision-making, patient autonomy, and communication quality within postoperative pain management.	Day 2 - 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with pain management	Patient satisfaction with pain management is assessed through two complementary measures: Overall satisfaction with pain treatment outcomes, rated on an 11-point NRS ranging from 0 (extremely dissatisfied) to 10 (extremely satisfied). Perceived adequacy of pain relief, expressed as a percentage from 0% (no relief) to 100% (complete relief), considering all pain treatments combined (pharmacological and non-pharmacological). This domain reflects the patient's global evaluation of analgesic effectiveness and quality of care.	Day 2 - 48 hours postoperatively
Time to return of bowel function	Time to return of bowel function was defined as the interval, in hours, from the end of the surgical procedure to the recovery of gastrointestinal motility. Outcome Components The return of bowel function was assessed based on the following clinical parameters: Time to first passage of flatus; Time to first bowel movement (defecation)	From D0 up to 1 month
Length of hospital stay.	Length of hospital stay; Time Frame: index admission	Day 30
Time to ambulation.	Time to ambulation; Time Frame: up to 48 hours.	Day 0, day 1 and day 2 - from the surgical procedure up to 48 hours postoperatively
Adverse events and complications related to TAP/BAP/systemic analgesia.		Day 30

Other Outcome Measures

Outcome Measure	Time Frame
Qualitative interview (5-10 min) on expectations, trust, coping, and emotional impact.	Day 2 - 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas de Minas Gerais
• Collaborators: Santa Casa de Misericórdia de Belo Horizonte

Publications and helpful links

General 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.
• Urits I, Schwartz R, Herman J, Berger AA, Lee D, Lee C, Zamarripa AM, Slovek A, Habib K, Manchikanti L, Kaye AD, Viswanath O. A Comprehensive Update of the Superior Hypogastric Block for the Management of Chronic Pelvic Pain. Curr Pain Headache Rep. 2021 Feb 25;25(3):13. doi: 10.1007/s11916-020-00933-0.
• De Silva P, Daniels S, Bukhari ME, Choi S, Liew A, Rosen DMB, Conrad D, Cario GM, Chou D. Superior Hypogastric Plexus Nerve Block in Minimally Invasive Gynecology: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):94-102. doi: 10.1016/j.jmig.2021.06.017. Epub 2021 Jun 29.
• Baeriswyl M, Zeiter F, Piubellini D, Kirkham KR, Albrecht E. The analgesic efficacy of transverse abdominis plane block versus epidural analgesia: A systematic review with meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11261. doi: 10.1097/MD.0000000000011261.
• Diaz-Cambronero O, Mazzinari G, Cata JP. Perioperative opioids and colorectal cancer recurrence: a systematic review of the literature. Pain Manag. 2018 Sep 1;8(5):353-361. doi: 10.2217/pmt-2018-0029. Epub 2018 Sep 13.
• Zeng J, Hong A, Gu Z, Jian J, Liang X. Efficacy of transversus abdominis plane block on postoperative nausea and vomiting: a meta-analysis of randomized controlled trial. BMC Anesthesiol. 2024 Mar 1;24(1):87. doi: 10.1186/s12871-024-02469-x.
• Lopez-Ruiz C, Orjuela JC, Rojas-Gualdron DF, Jimenez-Arango M, Rios JFL, Vasquez-Trespalacios EM, Vargas C. Efficacy of Transversus Abdominis Plane Block in the Reduction of Pain and Opioid Requirement in Laparoscopic and Robot-assisted Hysterectomy: A Systematic Review and Meta-analysis. Rev Bras Ginecol Obstet. 2022 Jan;44(1):55-66. doi: 10.1055/s-0041-1740595. Epub 2022 Jan 29.
• De Pinto M, Cahana A. Medical management of acute pain in patients with chronic pain. Expert Rev Neurother. 2012 Nov;12(11):1325-38. doi: 10.1586/ern.12.123.
• Aytuluk HG, Kale A, Basol G. Laparoscopic Superior Hypogastric Blocks for Postoperative Pain Management in Hysterectomies: A New Technique for Superior Hypogastric Blocks. J Minim Invasive Gynecol. 2019 May-Jun;26(4):740-747. doi: 10.1016/j.jmig.2018.08.008. Epub 2018 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): July 5, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; colorectal surgery; Ropivacaine; ERAS; TAP Block; Peripheral Autonomic Block; Superior Hypogastric Plexus; Inferior Mesenteric Plexus; Opioid-sparing Analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neurobehavioral Manifestations; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Chemically-Induced Disorders; Poisoning; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Colorectal Neoplasms; Bites and Stings; Agnosia; Surgical Equipment; Equipment and Supplies; Surgical Instruments
• Other Study ID Numbers: 84933224.2.0000.5138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share de-identified individual participant data (IPD) underlying the primary and secondary outcomes of this trial, including demographics, intraoperative variables necessary to interpret outcomes, postoperative pain scores at prespecified time points, cumulative opioid use (IV morphine equivalents), adverse events, length of stay, and discharge status. Direct identifiers and free-text notes will be removed; a re-identification key will be retained only at the site and will not be shared. Accompanying documents (final protocol, statistical analysis plan, data dictionary/codebook, blank CRFs, informed consent template, and analytic code for the primary analyses) will be provided. Access will be granted to qualified researchers with a methodologically sound proposal and IRB/ethics approval (or exemption) who sign a data-use agreement compliant with Brazil's LGPD (Law No. 13,709/2018) and institutional policies. Requests should be sent to the corresponding author.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results for 36 months (extensions considered upon reasonable request).
• IPD Sharing Access Criteria: Access will be granted to qualified researchers with a methodologically sound proposal and IRB/ethics approval (or exemption) who sign a data-use agreement compliant with Brazil's LGPD (Law No. 13,709/2018) and institutional policies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No