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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07388953
Acronym
BAPTAP
Enrollment
140
Registered
2026-02-05
Start date
2026-02-12
Completion date
2027-07-05
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

PROCEDUREMinimally Invasive Left-Sided Colorectal Resection

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

PROCEDUREBAPTAP (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.

PROCEDURETrocar/Incision Infiltration

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

Sponsors

Faculdade de Ciências Médicas de Minas Gerais
Lead SponsorOTHER
Santa Casa de Misericórdia de Belo Horizonte
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityDay 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperativelyPain 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 consumptionDay 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperativelyCumulative 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 postoperativelyPain 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 moodDay 2 - 48 hours postoperativelyThis 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 postoperativelyParticipation 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

MeasureTime frameDescription
Patient satisfaction with pain managementDay 2 - 48 hours postoperativelyPatient 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 to return of bowel functionFrom D0 up to 1 monthTime 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)
Length of hospital stay.Day 30Length of hospital stay; Time Frame: index admission
Time to ambulation.Day 0, day 1 and day 2 - from the surgical procedure up to 48 hours postoperativelyTime to ambulation; Time Frame: up to 48 hours.
Adverse events and complications related to TAP/BAP/systemic analgesia.Day 30

Countries

Brazil

Contacts

CONTACTMATHEUS MMMDE MEYER, MD
matheusww@gmail.com5531988044987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026