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

Condition(s) studied

Investigational drug(s) / intervention(s)

Minimally Invasive Left-Sided Colorectal Resection: Elective laparoscopic anterior/rectosigmoid resection or sigmoid colectomy per institutional standards; not randomized.

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.

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

Study 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.

Eligibility

Primary outcome measure(s)

• Pain intensity — 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.
• Cumulative opioid consumption — 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) \[+ (Tramadol mg ÷ 10) if applicable\].
• Pain frequency - Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO) — 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.
• Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO) - interference with activities and mood — 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.
• Participation - Patient-reported outcomes via PAIN OUT (Portuguese-validated IPO) — 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.

Trial sites (1)

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