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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFaculdade de Ciências Médicas de Minas Gerais

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective laparoscopic left-sided colorectal resection

ASA physical status I-II

Ability to understand the study and sign informed consent

Disqualifiers

Known allergy to study medications (e.g., local anesthetics)

Coagulation disorders

Pregnancy

Inability to understand or provide consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimally Invasive Left-Sided Colorectal Resection

    Procedure/Surgery

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

  • BAPTAP (Peripheral Autonomic Blockade + TAP Block)

    Procedure/Surgery

    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/Surgery

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block)Experimental treatment 2 interventions
Group B: Arm B - Control: Trocar/wound infiltration (Standard of Care)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

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

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) \[+ (Tramadol mg ÷ 10) if applicable\].

Time frame
Day 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperatively
3

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.

Time frame
Day 2 - 48 hours postoperatively
4

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.

Time frame
Day 2 - 48 hours postoperatively

Secondary outcomes

1

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.

Time frame
Day 2 - 48 hours postoperatively
2

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)

Time frame
From D0 up to 1 month
3

Length of hospital stay.

Length of hospital stay; Time Frame: index admission

Time frame
Day 30
4

Time to ambulation.

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

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

Other outcomes

1

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

Time frame
Day 2 - 48 hours postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Faculdade de Ciências Médicas de Minas Gerais

Lead sponsor

Santa Casa de Misericórdia de Belo Horizonte

Collaborator