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Double-Blind, Randomized Trial Comparing the Efficacy of One-Stage versus Two-Stage Laparoscopic Transversus Abdominis Plane Block in Minimally Invasive Colon and Rectal Surgery.

Double-Blind, Randomized Trial Comparing the Efficacy of One-Stage versus Two-Stage Laparoscopic Transversus Abdominis Plane Block in Minimally Invasive Colon and Rectal Surgery. - L-TAPB Pilot-RTC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036952
Enrollment
30
Registered
2025-06-10
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Patients aged =18 years (ASA physical status classification I–III) undergoing elective laparoscopic or robotic colorectal surgery, with or without stoma creation, including the following procedures: (Extended) right hemicolectomy, (Extended) left hemicolectomy, Transverse colon resection, Sigmoid resection, Subtotal colectomy (Low), anterior resection of the rectum

Interventions

Group 1: One-stage L-TAPB at the beginning of the surgery (200 mg ropivacaine) Group 2: Two-stage L-TAPB at the beginning and ending of the surgery (100 mg ropivacaine each)

Sponsors

Chirurgische Klinik, Universitätsmedizin Mannheim
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: atients aged =18 years undergoing elective laparoscopic or robotic colorectal surgery, with or without stoma creation, including the following procedures: (Extended) right hemicolectomy (Extended) left hemicolectomy Transverse colon resection Sigmoid resection Subtotal colectomy (Low) anterior resection of the rectum ASA physical status classification I–III

Exclusion criteria

Exclusion criteria: Language barrier Mental or cognitive impairment preventing the patient from understanding the nature, scope, and significance of the research project Glomerular filtration rate (GFR) < 30 mL/min Known chronic pain conditions Known allergies to local anesthetics

Design outcomes

Primary

MeasureTime frame
Evaluation of NRS pain scores based on patients' subjective pain experience in the time of 04/01/25 till 09/30/25.

Secondary

MeasureTime frame
Consumption of morphine milligram equivalents (MME) Use of metamizole and paracetamol Return of gastrointestinal function (time to first bowel movement/flatus and solid food intake) Postoperative nausea and vomiting (PONV) Postoperative mobility Adverse events related to the L-TAPB block Development of postoperative ileus Overall morbidity within the first 30 postoperative days, classified according to the Clavien-Dindo classification system Hospital readmission within 30 days postoperatively Length of postoperative hospital stay Intraoperative analgesia Patient satisfaction measured using the Numeric Rating Scale (NRS) DASS (Depression Anxiety Stress Scales) questionnaire QUIPS (Quality Improvement in Postoperative Pain Management) questionnaire, administered on postoperative day 1 at 8 a.m. Noxiousness Level (NOL)

Countries

Germany

Contacts

Public ContactJulia Hardt

Chirurgische Klinik, Universitätsmedizin Mannheim

julia.hardt@umm.de+49 06213832225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026