Colorectal CancerBAPTAPNCT07388953
Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)
A study testing Minimally Invasive Left-Sided Colorectal Resection, BAPTAP (Peripheral Autonomic Blockade + TAP Block) and Trocar/Incision Infiltration in people with Colorectal Cancer and Colorectal Surgery, run by Faculdade de Ciências Médicas de Minas Gerais at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Surgery, Anesthesia
- What is being tested?
- Minimally Invasive Left-Sided Colorectal Resection, BAPTAP (Peripheral Autonomic Blockade + TAP Block) and Trocar/Incision Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Feb 2026to 5 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparoscopic left-sided colorectal resection
- ASA physical status I-II
- Ability to understand the study and sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150221
Matheus MMM Meyer, MD, 5531988044987, drmatheusmeyer@gmail.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Colorectal Surgery, Anesthesia, Autonomic Nerve Block, Transversus Abdominis Plane (TAP) Block, Pain Management
- Being tested
- Minimally Invasive Left-Sided Colorectal Resection, BAPTAP (Peripheral Autonomic Blockade + TAP Block), Trocar/Incision Infiltration
- Keywords
- colorectal surgery, Postoperative Pain, Peripheral Autonomic Block, Superior Hypogastric Plexus, Inferior Mesenteric Plexus, TAP Block, ERAS, Ropivacaine, Opioid-sparing Analgesia
- Medical subject headings
- Colorectal Neoplasms, Bites and Stings, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Left-Sided Colorectal ResectionProcedure or surgery
Elective laparoscopic anterior/rectosigmoid resection or sigmoid colectomy per institutional standards; not randomized.
BAPTAP (Peripheral Autonomic Blockade + TAP Block)Procedure or 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 InfiltrationProcedure or surgery
General anesthesia with trocar/incision infiltration using 0.33% ropivacaine, up to a total volume of 60 mL.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Minimally Invasive Left-Sided Colorectal Resection; Procedure: Trocar/Incision Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 2 - 48 hours postoperatively
Secondary outcomes (5)
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.
Measured: Day 2 - 48 hours postoperatively
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)
Measured: From D0 up to 1 month
Length of hospital stay.
Length of hospital stay; Time Frame: index admission
Measured: Day 30
Time to ambulation.
Time to ambulation; Time Frame: up to 48 hours.
Measured: 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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start12 Feb 2026
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas de Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Belo Horizonte
- Responsible party
- Principal investigator, Alessandra Hubner de Souza, Faculdade de Ciências Médicas de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388953
- Sponsor's protocol ID
- 84933224.2.0000.5138
- Acronym
- BAPTAP
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data (IPD) underlying the primary and secondary outcomes of this trial, including demographics, intraoperative variables necessary to interpret outcomes, postoperative pain scores at prespecified time points, cumulative opioid use (IV morphine equivalents), adverse events, length of stay, and discharge status. Direct identifiers and free-text notes will be removed; a re-identification key will be retained only at the site and will not be shared. Accompanying documents (final protocol, statistical analysis plan, data dictionary/codebook, blank CRFs, informed consent template, and analytic code for the primary analyses) will be provided. 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. Requests should be sent to the corresponding author.
Publications
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.
PubMed 36050617Diaz-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.
PubMed 30212256Zeng 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.
PubMed 38429757Urits 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.
PubMed 33630172Lopez-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.
PubMed 35092960De 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.
PubMed 34197956De 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.
PubMed 23234394Baeriswyl 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.
PubMed 29952997Aytuluk 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.
PubMed 30165185
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07388953
- Acronym / sponsor ID
- BAPTAP / 84933224.2.0000.5138
- Conditions
- Colorectal Cancer, Colorectal Surgery, Anesthesia, Autonomic Nerve Block, Transversus Abdominis Plane (TAP) Block, Pain Management
- Keywords
- colorectal surgery, Postoperative Pain, Peripheral Autonomic Block, Superior Hypogastric Plexus, Inferior Mesenteric Plexus, TAP Block, ERAS, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Faculdade de Ciências Médicas de Minas GeraisUniversity, hospital or other
- Collaborators
- Santa Casa de Misericórdia de Belo Horizonte
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Jul 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block) | Experimental | Procedure: Minimally Invasive Left-Sided Colorectal Resection, Procedure: BAPTAP (Peripheral Autonomic Blockade + TAP Block)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. |
| Arm B - Control: Trocar/wound infiltration (Standard of Care) | Active comparator | Procedure: Minimally Invasive Left-Sided Colorectal Resection, Procedure: Trocar/Incision InfiltrationGeneral anesthesia and trocar/wound infiltration - ropivacaine 0.33% up to 60 mL total. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective laparoscopic left-sided colorectal resection
- ASA physical status I-II
- Ability to understand the study and sign informed consent
Key exclusion criteria (6 listed)
- Known allergy to study medications (e.g., local anesthetics)
- Coagulation disorders
- Pregnancy
- Inability to understand or provide consent
- Chronic pain on opioid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Left-Sided Colorectal ResectionElective laparoscopic anterior/rectosigmoid resection or sigmoid colectomy per institutional standards; not randomized. | Procedure or surgery | Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block), Arm B - Control: Trocar/wound infiltration (Standard of Care) |
| 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. | Procedure or surgery | Arm A - Experimental: BAPTAP (Peripheral Autonomic Block + TAP Block) |
| Trocar/Incision InfiltrationGeneral anesthesia with trocar/incision infiltration using 0.33% ropivacaine, up to a total volume of 60 mL. | Procedure or surgery | Arm B - Control: Trocar/wound infiltration (Standard of Care) |
Primary outcome
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.
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].
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.
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.
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.
5 secondary outcomes
Patient satisfaction with pain management
Time frame: Day 2 - 48 hours postoperatively
Time to return of bowel function
Time frame: From D0 up to 1 month
Length of hospital stay.
Time frame: Day 30
Time to ambulation.
Time frame: 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.
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 36050617Daes 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.
- Background: PubMed 30212256Diaz-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.
- Background: PubMed 38429757Zeng 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.
- Background: PubMed 33630172Urits 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.
- Background: PubMed 35092960Lopez-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.
- Background: PubMed 34197956De 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.
- Background: PubMed 23234394De 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.
- Background: PubMed 29952997Baeriswyl 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.
- Background: PubMed 30165185Aytuluk 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.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data (IPD) underlying the primary and secondary outcomes of this trial, including demographics, intraoperative variables necessary to interpret outcomes, postoperative pain scores at prespecified time points, cumulative opioid use (IV morphine equivalents), adverse events, length of stay, and discharge status. Direct identifiers and free-text notes will be removed; a re-identification key will be retained only at the site and will not be shared. Accompanying documents (final protocol, statistical analysis plan, data dictionary/codebook, blank CRFs, informed consent template, and analytic code for the primary analyses) will be provided. 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. Requests should be sent to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Left-Sided Colorectal Resection, BAPTAP (Peripheral Autonomic Blockade + TAP Block) and Trocar/Incision Infiltration in people with Colorectal Cancer and Colorectal Surgery, run by Faculdade de Ciências Médicas de Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MATHEUS MMMDE MEYER, MD (5531988044987, matheusww@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Day 0, day 1 and day 2 - From the surgical procedure up to 48 hours postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07388953, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.