Double-blind randomized comparison of the effect of the superior hypogastric plexus block (PHSB) in minimally invasive colorectal surgery – (PHSB Pilot-RCT)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038101

Enrollment

Registered

2025-10-10

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Pain, Gut

Interventions

Group 1: 15 patients do not receive a superior hypogastric plexus block during colorectal surgery. The standard procedure at the University Medical Center Mannheim is performed (=Transversus abdominis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients undergoing the following elective, minimally invasive procedures with or without stoma placement: o Sigmar resection including resection rectopexy o (deep) anterior rectal resection o intersphincteric rectal resection o Rectal excision • ASA Class I-III

Exclusion criteria

Exclusion criteria: • Language barrier • GFR < 30 ml/min • Known chronic pain • Allergies to local anesthetics such as ropivacaine • Chronic inflammatory bowel disease • Mental limitations that prevent the patient from understanding the nature, scope, and significance of the research project.

Design outcomes

Primary

Measure	Time frame
Patients' pain perception on the Numerical Rating Scale (NRS) until the end of the third postoperative day	—

Secondary

Measure	Time frame
• Morphine milligram-equivalent consumption • Consumption of metamizole and paracetamol • Return of gastrointestinal function (time to first bowel movement/flatus and solid food intake) • Nausea and vomiting • postoperative mobility • PHSB-related adverse events • Development of a postoperative ileus • Total morbidity in the first 30 days postoperatively, classified according to the Clavien-Dindo classification system • Inpatient readmission within the first 30 days after the operation • stationary postoperative bed rest duration • intraoperative analgesia • Patient satisfaction on the Numerical Rating Scale (NRS) • DASS (Depression-Anxiety-Stress Scale) questionnaire • QUIPS (Quality Improvement in Postoperative Pain Therapy) questionnaire on the first postoperative day at 8:00 AM • Noxiousness Level (NOS)	—

Measure

Time frame

• Morphine milligram-equivalent consumption • Consumption of metamizole and paracetamol • Return of gastrointestinal function (time to first bowel movement/flatus and solid food intake) • Nausea and vomiting • postoperative mobility • PHSB-related adverse events • Development of a postoperative ileus • Total morbidity in the first 30 days postoperatively, classified according to the Clavien-Dindo classification system • Inpatient readmission within the first 30 days after the operation • stationary postoperative bed rest duration • intraoperative analgesia • Patient satisfaction on the Numerical Rating Scale (NRS) • DASS (Depression-Anxiety-Stress Scale) questionnaire • QUIPS (Quality Improvement in Postoperative Pain Therapy) questionnaire on the first postoperative day at 8:00 AM • Noxiousness Level (NOS)

—

Countries

Germany

Contacts

Public ContactJulia Hardt

Universitätsmedizin Mannheim (Universität Heidelberg), Prof. Dr. med. Julia Hardt

julia.hardt@umm.de+49 6213831501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026