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NCT Number: NCT07388953

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally Invasive Left-Sided Colorectal Resection

Procedure

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

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.

Trocar/Incision Infiltration

Procedure

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

Primary outcomes

  1. Pain intensity

    Time frame: Day 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperatively

    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.

  2. Cumulative opioid consumption

    Time frame: Day 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperatively

    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].

  3. Pain frequency - Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO)

    Time frame: Day 2 - 48 hours postoperatively

    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.

  4. Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO) - interference with activities and mood

    Time frame: Day 2 - 48 hours postoperatively

    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.

  5. Participation - Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO)

    Time frame: Day 2 - 48 hours postoperatively

    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.

Secondary outcomes

  1. Patient satisfaction with pain management

    Time frame: Day 2 - 48 hours postoperatively

    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.

  2. Time to return of bowel function

    Time frame: From D0 up to 1 month

    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)
  3. Length of hospital stay.

    Time frame: Day 30

    Length of hospital stay; Time Frame: index admission

  4. Time to ambulation.

    Time frame: Day 0, day 1 and day 2 - from the surgical procedure up to 48 hours postoperatively

    Time to ambulation; Time Frame: up to 48 hours.

  5. Adverse events and complications related to TAP/BAP/systemic analgesia.

    Time frame: Day 30

Other outcomes

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

    Time frame: Day 2 - 48 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

MATHEUS MMMDE MEYER, MD

CONTACT

[email protected]

5531988044987

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas de Minas Gerais

Other

Collaborators

  • Santa Casa de Misericórdia de Belo Horizonte

Registry information

Official study title

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

Acronym: BAPTAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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