Post Operative AnalgesiaNCT06694207
Effect of Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl for Post-Operative Analgesia Following Laparoscopy in Pediatric Patients
An observational study of Post Operative Analgesia, run by Assiut University.
Trial summary
To compare analgesic effect of adding dexmedomedin or fentanyl to intraperitoneal bupivacain in pediatric patients undergoing laparoscopy. The primary outcome is to compare pain using the Children's Hospital of Eastern Ontario score (CHEOPS). Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: This prospective study will include pediatric patients who will be admitted to hospitals of Assuit University including Children from both sexes, Children aged 6-9 years old, Have the American Society of Anesthesiologists (ASA) physical status I or II and those who will undergo laparoscopy.
Who may be able to join
- Who will undergo laparoscopy.
Who cannot join
- Children with a known history of Heart disease, Local anesthetic allergy, and Body mass index of ≥95th percentile for age.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohamed Sayed Hassanein, professor of Anesthesia contact
About this study
To compare analgesic effect of adding dexmedomedin or fentanyl to intraperitoneal bupivacain in pediatric patients undergoing laparoscopy. The primary outcome is to compare pain using the Children's Hospital of Eastern Ontario score (CHEOPS). The secondary goal is to compare the time to the first request for analgesia in the post-operative period, the total dose of analgesics used in the 24 hours (post-operative), side effects, and signs of systemic absorption and toxicity.
Read the detailed description
Laparoscopic procedures have many advantages over open procedures such as lesser hemorrhage , better cosmetic results, lesser postoperative pain and shorter recovery time leading to a shorter hospital stay and less expenditure . Laparoscopic procedures are associated with postoperative pain affecting early ambulation of the patient. Pain in laparoscopic surgery results from stretching of the abdominal cavity, peritoneal inflammation, diaphragmatic irritation and residual carbon dioxide (CO2) in the peritoneal cavity . Peritoneal irritation by carbonic acid (formed by reaction between carbon dioxide CO2 and water) and the creation of space between the liver and diaphragm by residual pneumoperitoneum has been implicated for visceral and shoulder tip pain. Humidity and volume of the insufflated gas, wound size, and trauma to the parietal peritoneum may also be responsible for this pain. A multimodal approach is required to alleviate all three types of pain which includes parenteral NSAIDs, opioids, and postoperative intraperitoneal local anesthetic instillation, port-site infiltration of local anesthetic, intra-peritoneal saline, removal of insufflation gas, gas drains, low-pressure abdominal insufflations, acetazolamide administration and use of N2O in place of CO2, etc. Intraperitoneal local anesthetic (IPLA) appears promising in pediatric surgery although the high absorptive capacity of the peritoneum and high peritoneal surface area in children. Hence, the delivery of an effective dose without toxicity in children could be challenging. Fentanyl selectively binds to the mu-receptor in the central nervous system (CNS). Stimulation of the mu-subtype opioid receptor stimulates the exchange of GTP for GDP on the G-protein complex and subsequently inhibits adenylate cyclase, so decreasing in intracellular cAMP and leads to a reduction in the release of neurotransmitters. It was found that administering either fentanyl or ketamine as an LA adjuvant dramatically speed up the onset of anesthesia, prolonged the duration of lid akinesia, increased the duration of globe akinesia, and lengthened the time for the first request of postoperative analgesia. Opioids, in conjunction with local anesthetics, improve the quality of intraoperative analgesia and prolong the duration of postoperative analgesia. Although morphine was the first opioid used, a wide variety of clinically relevant side effects, especially respiratory depression, limited its utility. In contrast, a favorable pharmacokinetic and pharmacodynamic profile of lipophilic opiates (fentanyl) proved to be a better alternative as their lipophilicity leads to rapid uptake and faster clinical onset of action and short duration of action. Dexmedetomidine (alpha-2 adrenergic agonists) has become one of the frequently used drugs in anesthesia as it has been reported to provide analgesia, anxiolysis, and an anesthetic-sparing action with minimal respiratory depression plus its sedative effect that mimics natural sleep. Intraperitoneal instillation of dexmedetomidine with bupivacaine reduces the pain after elective laparoscopy in adults as compared to that with bupivacaine alone or with tramadol. In addition, the postoperative requirement for rescue analgesia is reduced. The purpose of the study is to assess and compare the analgesic effectiveness of intraperitoneal bupivacaine in paediatric patients with either fentanyl or Dexmedotomidine.
- Conditions
- Post Operative Analgesia
- Being tested
- Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal Bupivacaine with Dexmedotomidine or FentanylDrug
Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl for Post-Operative Analgesia Following Laparoscopy in Pediatric Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to compare pain using the Children's Hospital of Eastern Ontario score (CHEOPS)
compare the time to the first request for analgesia in the post-operative period, the total dose of analgesics used in the 24 hours (post-operative), side effects, and signs of systemic absorption and toxicity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Youssef Roshdy Kelada, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694207
- Sponsor's protocol ID
- Intraperitoneal Bupivacaine
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaarthika T, Radhapuram SD, Samantaray A, Pasupuleti H, Hanumantha Rao M, Bharatram R. Comparison of effect of intraperitoneal instillation of additional dexmedetomidine or clonidine along with bupivacaine for post-operative analgesia following laparoscopic cholecystectomy. Indian J Anaesth. 2021 Jul;65(7):533-538. doi: 10.4103/ija.IJA_231_21. Epub 2021 Jul 23.
PubMed 34321684