Ultrasound-guided ilioinguinal-iliohypogastric block or perifocal wound infiltration in children: a prospective randomized comparison of analgesia quality, a pilot study
Organizational Data
- DRKS-ID:
- DRKS00020987
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-03-20
- Last update in DRKS:
- 2020-11-05
- Registration type:
- Retrospective
Acronym/abbreviation of the study
UIHBOPWIIC
URL of the study
No Entry
Brief summary in lay language
The Ilioinguinal-iliohypogastric block (ILIHB) and perifocal wound infiltrtaion (PWI) are both established regional anaesthesia procedures for inguinal surgery in children. Data availability for comparing ultrasound-guided blocks versus wound infiltration, by means of ultrasound-guided procedures, is still absent. Ultrasound guided ILIHB ensures better postoperative analgesia in children and should be prioritized over postoperative PWI.
Brief summary in scientific language
Background: Ilioinguinal-iliohypogastric block (ILIHB) is a well-established procedure for postoperative analgesia after open inguinal surgery in children. This procedure is effective and safe, especially when ultrasound is used. Data availability for comparing ultrasound-guided blocks versus wound infiltration is still weak. The study was designed to determine the efficacy of ultrasound-guided ILIHB (US-ILIHB) on postoperative pain control in pediatric patients following a inguinal daycase surgery, compared with perifocal wound infiltration (PWI) by the surgeon. Methods: This randomized, double-blinded trail was conducted in pediatric patients aged from 6 months to 4 years. The total number of children included in the study was 103. Patients were allocated in two groups. The ILIHB group recieved 0,2% ropivacain for US-ILIHB after anesthesia induction. The PWI group recieved 0,2% ropivavain for PWI performed by a surgeon before wound closure. Parameters recorded included the postoperative pain score, pain frequency, time to first analgesics and consumption of analgesics. Results: US-ILIHB significantly reduced the occurrence of pain within the first 24 hours after surgery (7.7%, p = 0.01). Moreover, the pain-free interval until administration of the first dose of opioids was 21 minutes longer, on average (p = 0.003), following US-ILIHB compared to perifocal wound infiltration. 72% of children who received US-ILIHB did not require additional opioids, as compared to 56% of those who received PWI. Conclusion: Thus our study demonstrates that US-ILIHB ensures better postoperative analgesia in children and should be prioritized over postoperative PWI.
Health condition or problem studied
- Free text:
- Efficacy of ultrasound-controlled ILIHB (US-ILIHB) via postoperative pain control in pediatric patients after outpatient groin surgery
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Ilioinbuinal-Iliohypogastric Block
- Arm 2:
- Perficoal Wound Infiltration
Endpoints
- Primary outcome:
- Measurement of the postoperative pain score in the recovery room using a pain assessment questionnaire
- Secondary outcome:
- Calculate the total painkiller requirement as well as the time until the first painkiller administration
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Kinderkrankenhaus Altona Hamburg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2017-02-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-05-01
- Target Sample Size:
- 120
- Final Sample Size:
- 103
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 6 Months
- Maximum Age:
- 4 Years
- Additional Inclusion Criteria:
- 6 months - 4 years, ASAI-II, unilateral daycase inguinal surgery
Exclusion Criteria
Diseases, Allergies, Emergencies, multiple interventions
Addresses
Primary Sponsor
- Address:
- Kinderkrankenhaus Altona KinderchirurgieProf. Konrad ReinshagenBleickenallee 3822763 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Altonaer Kinderkrankenhaus Hamburg /UKE Hamburg KinderchirurgieProf. Konrad ReinshagenBleickenalle 3822763 HamburgGermany
- Telephone:
- 04088908230
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kinderkrankenhaus.net/unsere-medizinischen-bereiche-im-ueberblick/fachabteilungen/kinderchirurgie-im-altonaer-kinderkrankenhaus.html
Contact for Public Queries
- Address:
- Altonaer Kinderkrankenhaus Hamburgdes/ UKE Hamburg KinderchirurgieProf. Konrad ReinshagenBleickenallee 3822763 HamburgGermany
- Telephone:
- 04088908230
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kinderkrankenhaus.net/unsere-medizinischen-bereiche-im-ueberblick/fachabteilungen/kinderchirurgie-im-altonaer-kinderkrankenhaus.html
Principal Investigator
- Address:
- Altonaer Kinderkrankenhaus Hamburg /UKE Hamburg KinderchirurgieProf. Konrad ReinshagenBleickenalle 3822763 HamburgGermany
- Telephone:
- 04088908230
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kinderkrankenhaus.net/unsere-medizinischen-bereiche-im-ueberblick/fachabteilungen/kinderchirurgie-im-altonaer-kinderkrankenhaus.html
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Kinderkrankenhaus Altona22763 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Altonaer Kinderkrankenhaus Hamburg KinderchirurgieBleickenallee 3822763 HamburgGermany
- Telephone:
- 04088908230
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-2022990
- Fax:
- +40-40-202299410
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-03-17
- Ethics committee number:
- PV5270
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-05-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- study protocol
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Grosse et al. BMC Anesthesiology (2020) 20:256
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry