- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913205
Rectus Sheath Block and Local Wound Infiltration in Pediatric Laparoscopic Appendectomies
Comparison of Regional Block Techniques Used for Postoperative Pain Management in Laparoscopic Appendectomy in Children
Study Overview
Status
Detailed Description
Acute appendectomy surgeries are one of the most frequently performed surgeries in childhood. Minimally invasive (laparoscopic) surgical methods are recommended, especially in abdominal surgeries, due to rapid wound healing, rapid recovery, less bleeding, and shorter hospital stays compared to open surgery. In addition to all these advantages of laparoscopic surgeries, postoperative somatic pain is expected to be less compared to open surgeries due to the small incisions in the abdominal wall. However, when the pain severity of children who underwent laparoscopic appendectomy was evaluated using the pain scoring scale, it was seen that the median pain scores were ≥7 in 5% of the children (severe pain) and ≥4 in 25% (moderate pain). Clinical practice guidelines also recommend the use of regional anesthesia and analgesia methods as part of multimodal analgesia in the prevention of intraoperative and postoperative pain. We also routinely use regional anesthesia and analgesia methods successfully and effectively in our daily practices in our clinic.
Rectus sheath blocks, which are known to be effective in midline incisions, and local anesthetic infiltrations of the wound site, which do not require special technical knowledge about regional anesthesia, are routinely applied in our clinic in every case. Although both methods provide clinical benefits, it is unknown which one is superior to the other.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bursa, Turkey, 16110
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Older than 8 years
- Younger than 18 years
- Minimal invasive appendectomy (3 port)
- Consent to participate
Exclusion Criteria:
- Younger than 8 years
- Older than 18 years
- Convert to open abdominal surgery
- Do not consent to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Rectus Sheath Block
Children undergoing laparoscopic appendectomy with rectus sheath blocks
|
|
Local infiltration
Children undergoing laparoscopic appendectomy with local infiltration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analgesic consumption
Time Frame: Postoperative first 24 hours.
|
Total acetaminophen use in the first 24 hours after surgery
|
Postoperative first 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain scores
Time Frame: Postoperative first 24 hours.
|
Pain scores will be evaluated in the postoperative period using the Wong-Baker Faces Pain Rating Scale, where zero is equivalent to no pain, and 10 indicates the worst possible pain.
|
Postoperative first 24 hours.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.
- Hamill JK, Liley A, Hill AG. Rectus sheath block for laparoscopic appendicectomy: a randomized clinical trial. ANZ J Surg. 2015 Dec;85(12):951-6. doi: 10.1111/ans.12950. Epub 2015 Jan 12.
- Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-KAEK-25 2021/08-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Anesthesia
-
Children's Hospital of PhiladelphiaErasmus Medical Center; University of Texas Southwestern Medical Center; Children... and other collaboratorsCompletedPediatric Anesthesia | General Anesthesia | ElectroencephalographyUnited States, Australia, Switzerland, China, Netherlands
-
Gødstrup HospitalAarhus University HospitalRecruitingPediatric Anesthesia | PROMs | Pediatric Surgery | PREMsDenmark
-
Bozok UniversityEnrolling by invitationPediatric AnesthesiaTurkey
-
Bürgerhospital FrankfurtCompleted
-
Tanta UniversityCompleted
-
Baylor College of MedicineRecruitingPediatric AnesthesiaUnited States
-
Wake Forest University Health SciencesCompleted
-
Istanbul University - CerrahpasaNot yet recruitingPediatric Anesthesia | Pediatric Postoperative Recovery | Pediatric Enhanced Recovery After SurgeryTurkey (Türkiye)
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingPediatric Anesthesia | Airway Management | General Anesthesia | LMAChina
-
ACPM Medical CollegeCompletedPediatric Spinal Anesthesia