Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial.
Jorge Daes, David J Morrell, Andrés Hanssen...
https://pubmed.ncbi.nlm.nih.gov/36050617Actively Recruiting
Led by Faculdade de Ciências Médicas de Minas Gerais · Updated on 2026-02-13
140
Participants Needed
1
Research Sites
30 weeks
Total Duration
F
Faculdade de Ciências Médicas de Minas Gerais
Lead Sponsor
S
Santa Casa de Misericórdia de Belo Horizonte
Collaborating Sponsor
Researchers are evaluating two pain management strategies for adults undergoing elective laparoscopic left-sided colorectal surgery. This randomized, controlled, double-blind trial compares conventional postoperative analgesia using intravenous medications and surgical wound infiltration with a combined locoregional approach involving a peripheral autonomic plexus block and a transversus abdominis plane (TAP) block. The goal is to see if the combined method reduces pain intensity and opioid use in the first 48 hours after surgery. The study involves 140 adults aged 18 to 80 years with ASA physical status I-II, scheduled for minimally invasive left-sided colorectal resection. Participants are randomly assigned to one of two groups: the experimental group receives a laparoscopic peripheral autonomic plexus block targeting the superior hypogastric and inferior mesenteric plexuses with ropivacaine, plus a bilateral ultrasound-guided TAP block also with ropivacaine, alongside standard multimodal analgesia. The control group receives the standard multimodal analgesia plus trocar and wound infiltration with ropivacaine without the autonomic or TAP blocks. The anesthesiologist performing the block is unblinded but does not participate in postoperative care or evaluations, while participants and outcome assessors are blinded. Participants will be closely monitored for pain intensity at rest using a Numerical Rating Scale at 2, 6, 12, 24, and 48 hours after surgery, as well as for total opioid consumption during the first 48 hours. Secondary assessments include time to bowel function return, ambulation, length of hospital stay, complications related to the blocks or analgesia, patient satisfaction, and quality of recovery measured by the PAIN OUT questionnaire. Adverse events will be followed for up to 30 days postoperatively, and a brief interview will explore patient experiences related to expectations and emotional impact. The total study duration for each participant covers the surgery and follow-up period up to one month.
CONDITIONS
Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus 48 hours postoperatively
Participants undergo minimally invasive left-sided colorectal surgery with either peripheral autonomic plexus block plus bilateral TAP block or trocar/wound infiltration, combined with standardized multimodal analgesia for postoperative pain control.
1 surgery visit and assessments up to 48 hours after surgery
Duration - Up to 30 days after surgery
Participants are monitored for functional recovery, adverse events related to blocks or analgesia, and patient-reported outcomes including pain and satisfaction for up to 30 days after surgery.
Visits or contacts as needed during the 30-day postoperative period
Total: 1 location
1
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150221
Actively Recruiting
M
MATHEUS MMMDE MEYER, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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