NCT04590027

Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

Completed Results posted Last updated 14 July 2021

What this trial tests

trial in Anesthesia, Caudal in 86 participants. Completed in 30 January 2020.

Timeline

1 February 2014

Primary endpoint
30 June 2015

30 January 2020

Quick facts

Lead sponsor	University Hospital Tuebingen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	86
Start date	1 February 2014
Primary completion	30 June 2015
Estimated completion	30 January 2020

Conditions studied

• Anesthesia, Caudal — all drugs for Anesthesia, Caudal →

Sponsor

University Hospital Tuebingen

Who can join

Adults 3 Months to 68 Months, any sex, with Anesthesia, Caudal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Comparison of Analgesia Quality Between the Two Groups Primary · Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,

Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management

Arrival PCU

Group	Value	95% CI
Caudal Block	1.86	± 0.43
Local Infiltration	3.09	± 0.51

Arrival ward

Group	Value	95% CI
Caudal Block	1.83	± 0.5
Local Infiltration	2.95	± 0.58

1h

Group	Value	95% CI
Caudal Block	1.36	± 0.31
Local Infiltration	2.13	± 0.37

2h

Group	Value	95% CI
Caudal Block	1.3	± 0.33
Local Infiltration	1.68	± 0.39

3h

Group	Value	95% CI
Caudal Block	1.43	± 0.31
Local Infiltration	1.54	± 0.36

4h

Group	Value	95% CI
Caudal Block	2.0	± 0.34
Local Infiltration	0.86	± 0.40

5h

Group	Value	95% CI
Caudal Block	1.76	± 0.34
Local Infiltration	0.77	± 0.40

6h

Group	Value	95% CI
Caudal Block	1.5	± 0.28
Local Infiltration	1.00	± 0.33

Set up Time Secondary · Time in minutes measured between start of induction of anesthesia to start of surgical incision

How much times goes by for induction of anesthesia in both groups

Group	Value	95% CI
Caudal Block	22.5	16 – 46
Local Infiltration	17	10 – 35

Rescue Medication Secondary · 24 hours

total number of analgesic doses across all participants

Group	Value	95% CI
Caudal Block	58
Local Infiltration	31

Adverse events — posted to ClinicalTrials.gov

Time frame: 0-24 h postoperatively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Caudal Block

Serious: 0/30 (0%)

Deaths: 0/30

Local Infiltration

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (2 terms — click to expand)

Reaction	System	Caudal Block	Local Infiltration
vomiting	Gastrointestinal disorders	—	—
delayed micturation	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT04590027 adverse events section.

Sponsor's own description

Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.