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

NCT07388953 | Recruiting

• 1 other identifier: 84933224.2.0000.5138
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Colorectal Surgery; Anesthesia; Autonomic Nerve Block; Pain Management; Transversus Abdominis Plane (TAP) Block; Post Operative Analgesia

Keywords

colorectal surgery; Postoperative Pain; Peripheral Autonomic Block; Superior Hypogastric Plexus; Inferior Mesenteric Plexus; TAP Block; ERAS; Ropivacaine; Opioid-sparing Analgesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Patient satisfaction with pain management

  Day 2 - 48 hours postoperatively

• Time to return of bowel function

  From D0 up to 1 month

• Length of hospital stay.

  Day 30

• Time to ambulation.

  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 Outcomes (1)

• Qualitative interview (5-10 min) on expectations, trust, coping, and emotional impact.

  Day 2 - 48 hours postoperatively

Study Arms (2)

Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block)

EXPERIMENTAL

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; Procedure: BAPTAP (Peripheral Autonomic Blockade + TAP Block)

Arm B - Control: Trocar/wound infiltration (Standard of Care)

ACTIVE COMPARATOR

General anesthesia and trocar/wound infiltration - ropivacaine 0.33% up to 60 mL total.

Procedure: Minimally Invasive Left-Sided Colorectal Resection; Procedure: Trocar/Incision Infiltration

Interventions

Minimally Invasive Left-Sided Colorectal Resection PROCEDURE

Elective laparoscopic anterior/rectosigmoid resection or sigmoid colectomy per institutional standards; not randomized.

Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block); Arm B - Control: Trocar/wound infiltration (Standard of Care)

BAPTAP (Peripheral Autonomic Blockade + TAP Block) PROCEDURE

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.

Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block)

Trocar/Incision Infiltration PROCEDURE

General anesthesia with trocar/incision infiltration using 0.33% ropivacaine, up to a total volume of 60 mL.

Arm B - Control: Trocar/wound infiltration (Standard of Care)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Ciências Médicas de Minas Gerais: lead
• Santa Casa de Misericórdia de Belo Horizonte: collaborator

Study Sites (1)

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150221, Brazil

RECRUITING

Related Publications (9)

• 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

• 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.

  PMID: 30212256 BACKGROUND

• 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.

  PMID: 38429757 BACKGROUND

• 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.

  PMID: 33630172 BACKGROUND

• 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.

  PMID: 35092960 BACKGROUND

• 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.

  PMID: 34197956 BACKGROUND

• 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.

  PMID: 23234394 BACKGROUND

• 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.

  PMID: 29952997 BACKGROUND

• 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.

  PMID: 30165185 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Bites and Stings; Agnosia; Pain, Postoperative

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Central Study Contacts

MATHEUS MMMDE MEYER, MD

CONTACT

5531988044987; matheusww@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: andomization occurs at the participant level with no crossover; the anesthesiologist performing the block is unblinded and is not involved is not involved in postoperative care or outcome assessments, while participants, and assessors remain masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This is a single-center, individually randomized (1:1), two-arm, parallel-assignment, superiority trial. All participants receive standardized general anesthesia and perioperative ERAS care. Arm A (BAPTAP) receives a laparoscopic peripheral autonomic plexus block targeting the superior hypogastric and inferior mesenteric plexuses with ropivacaine 0.2% (8 mL per site) performed before dissection, plus a bilateral ultrasound-guided transversus abdominis plane (TAP) block with ropivacaine 0.33% (30 mL per side). Arm B (control) receives general anesthesia with trocar/wound infiltration only, without autonomic plexus or TAP blocks; postoperative analgesia follows the institutional ERAS protocol. Randomization occurs at the participant level with no crossover; the anesthesiologist performing the block is unblinded and is not involved is not involved in postoperative care or outcome assessments, while participants, and assessors remain masked.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 5, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): July 5, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary results for 36 months (extensions considered upon reasonable request).
• 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.

Locations

BR (1)