CholecystitisNCT04838379
Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block
A study testing Dexmedetomidine in people with Cholecystitis and Appendicitis, run by Assiut University at 1 site in Egypt.
Trial summary
The current study aimed to assess the efficacy of Dexmedetomidine (DEX) and Dexamethasone as an adjuvant to ultrasound guided TAP and RS block to prolongation of postoperative analgesia and better pain control in children undergoing laparoscopic surgeries Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cholecystitis, Appendicitis
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ● Age: 8-12years.
- Weight: 20-60 kg.
- Sex: both males and females.
- ASA physical status: I-II.
Who cannot join
- • Patient's guardian refusal to participate in the study.
- Patients having known hypersensitivity to dexametomidine will be excluded.
- Patients with cardiovascular, liver or renal disease, unsatisfactory preoperative peripheral arterial oxygen saturation, neurological or psychiatric disease and coagulation disturbances.
- Any perioperative cardiovascular or respiratory event occurred or difficulties in pain perception and assessment which make the study intervention clinically unacceptable.
- Patients on regular use of analgesic or who received analgesic 24 h before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesic Effect of Preemptive Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block With Dexmedetomidine vs Dexamethasone for Laparoscopic Surgery in Paediatrics
The current study aimed to assess the efficacy of Dexmedetomidine (DEX) and Dexamethasone as an adjuvant to ultrasound guided TAP and RS block to prolongation of postoperative analgesia and better pain control in children undergoing laparoscopic surgeries
Read the detailed description
Laparoscopic surgeries are one of the most frequently performed paediatric surgeries . Although minimally invasive, this technique is still associated with a significant amount of pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend to have more postoperative pain, delayed hospital discharge, and higher incidence of emergence delirium, sleep disturbances, and other mal-adaptive behaviour changes that can last up to a few weeks following surgery . To improve analgesia and decrease postoperative anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain control can be employed.
Over the past years, the concept of pain management has extended from simply decreasing pain intensity to optimizing patient's condition. The goal is to decrease pain scores, stress response that should be avoided in patients, particularly cardiac patients, together with a decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and over sedation. By achieving these goals, we can certainly facilitate patient recovery and minimize the hospital stay. Improved pain control can be achieved by a combination of different types of regional analgesia with systemic analgesics. The main contributor to pain post abdominal operations is the pain from abdominal wall incision .
Many procedures were followed to decrease this intense postoperative pain such as, epidural catheter analgesia, transversus abdominis plane (TAP) block, local wound infiltration, Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to systemic administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids .
The transversus abdominis plane (TAP) block is a regional anesthetic technique that provides analgesia to the parietal peritoneum as well as to the skin and muscles of the anterior abdominal wall (9-10). Despite a relatively low risk of complications and a high success rate using modern techniques, TAP block remains overwhelmingly underused. Although the technique is technically straightforward, it has not been adopted in clinical practice .
Moreover, The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable for operations with a midline incision or laparoscopic surgery with the main incision at the umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus sheath block for laparoscopic appendectomy compared to a control group injected with saline instead of a local anesthetic Generally, in laparoscopic surgeries, the sites of port incision are associated with considerable postoperative discomfort. Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient outcomes. In addition to the usefulness of traditional local anesthetics to provide analgesia during the course of the postoperative period is restricted by their short duration of action .
Dexmedetomidine (DEX) and Dexamethasone has been shown as a valuable additives to local anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of postoperative analgesia and better pain control .
Dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoreceptors (α-2a, α-2b and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the mental state .
Dexamethasone, a high-potency, long-acting glucocorticoid, has been shown to prolong peripheral nerve blockade . Dexamethasone binds to glucocorticoid receptors and inhibits potassium conductance, which decreases nociceptive C-fiber activity . Dexamethasone may also extend the duration of analgesia via local vasoconstrictive and systemic anti-inflammatory effects .
Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient outcomes.
.
- Conditions
- Cholecystitis, Appendicitis
- Being tested
- Dexmedetomidine
- Keywords
- us guided rectus sheath block&tap block, laparscopic surgery, regional anesthesia
- Medical subject headings
- Cholecystitis, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexamethasone, Bupivacaine
Ninety patients were randomized to receive ultrasound-guided RSB\&tap block After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block \& tap block was performed
| Study group | Role | What they receive |
|---|---|---|
| group Bupivacaine | Placebo comparator | will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline, 10 minutes before skin incision Receives: Drug: Dexmedetomidine |
| group bupivacaine&dex | Active comparator | will include 30 patients: each one will receive 2.5mg/kg of 0.25% bupivacaine plus 1 µ/kg of dexmedetomidine diluted in a 20 mL syringe of normal saline, 10 minutes before skin incision Receives: Drug: Dexmedetomidine |
| Group bupivacaine & dexamethasone | Active comparator | will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine plus dexamethasone (0.3 mg/kg) diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the first call for rescue analgesia
the time of the first call for analgesia is recorded
Measured: 24 hours after recovery from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Apr 2021
- Primary completion20 May 2022
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Age: 8-12years. * Weight: 20-60 kg. * Sex: both males and females. * ASA physical status: I-II.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirolos Gamal Reda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838379
- Sponsor's protocol ID
- 01210861577
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesic Effect of Preemptive Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block With Dexmedetomidine vs Dexamethasone for Laparoscopic Surgery in Paediatrics
- ClinicalTrials.gov ID
- NCT04838379
- Acronym / sponsor ID
- 01210861577
- Conditions
- Cholecystitis, Appendicitis
- Keywords
- us guided rectus sheath block&tap block, laparscopic surgery, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aimed to assess the efficacy of Dexmedetomidine (DEX) and Dexamethasone as an adjuvant to ultrasound guided TAP and RS block to prolongation of postoperative analgesia and better pain control in children undergoing laparoscopic surgeries
Detailed description
Laparoscopic surgeries are one of the most frequently performed paediatric surgeries . Although minimally invasive, this technique is still associated with a significant amount of pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend to have more postoperative pain, delayed hospital discharge, and higher incidence of emergence delirium, sleep disturbances, and other mal-adaptive behaviour changes that can last up to a few weeks following surgery . To improve analgesia and decrease postoperative anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain control can be employed.
Over the past years, the concept of pain management has extended from simply decreasing pain intensity to optimizing patient's condition. The goal is to decrease pain scores, stress response that should be avoided in patients, particularly cardiac patients, together with a decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and over sedation. By achieving these goals, we can certainly facilitate patient recovery and minimize the hospital stay. Improved pain control can be achieved by a combination of different types of regional analgesia with systemic analgesics. The main contributor to pain post abdominal operations is the pain from abdominal wall incision .
Many procedures were followed to decrease this intense postoperative pain such as, epidural catheter analgesia, transversus abdominis plane (TAP) block, local wound infiltration, Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to systemic administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids .
The transversus abdominis plane (TAP) block is a regional anesthetic technique that provides analgesia to the parietal peritoneum as well as to the skin and muscles of the anterior abdominal wall (9-10). Despite a relatively low risk of complications and a high success rate using modern techniques, TAP block remains overwhelmingly underused. Although the technique is technically straightforward, it has not been adopted in clinical practice .
Moreover, The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable for operations with a midline incision or laparoscopic surgery with the main incision at the umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus sheath block for laparoscopic appendectomy compared to a control group injected with saline instead of a local anesthetic Generally, in laparoscopic surgeries, the sites of port incision are associated with considerable postoperative discomfort. Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient outcomes. In addition to the usefulness of traditional local anesthetics to provide analgesia during the course of the postoperative period is restricted by their short duration of action .
Dexmedetomidine (DEX) and Dexamethasone has been shown as a valuable additives to local anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of postoperative analgesia and better pain control .
Dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoreceptors (α-2a, α-2b and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the mental state .
Dexamethasone, a high-potency, long-acting glucocorticoid, has been shown to prolong peripheral nerve blockade . Dexamethasone binds to glucocorticoid receptors and inhibits potassium conductance, which decreases nociceptive C-fiber activity . Dexamethasone may also extend the duration of analgesia via local vasoconstrictive and systemic anti-inflammatory effects .
Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient outcomes.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Age: 8-12years. * Weight: 20-60 kg. * Sex: both males and females. * ASA physical status: I-II.
| Arm | Type | Receives |
|---|---|---|
| group Bupivacaine | Placebo comparator | Drug: Dexmedetomidinewill include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline, 10 minutes before skin incision |
| group bupivacaine&dex | Active comparator | Drug: Dexmedetomidinewill include 30 patients: each one will receive 2.5mg/kg of 0.25% bupivacaine plus 1 µ/kg of dexmedetomidine diluted in a 20 mL syringe of normal saline, 10 minutes before skin incision |
| Group bupivacaine & dexamethasone | Active comparator | Drug: Dexmedetomidinewill include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine plus dexamethasone (0.3 mg/kg) diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ● Age: 8-12years.
Key exclusion criteria (5 listed)
- • Patient's guardian refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexamethasone, BupivacaineNinety patients were randomized to receive ultrasound-guided RSB\&tap block After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block \& tap block was performed | Drug | Group bupivacaine & dexamethasone, group Bupivacaine, group bupivacaine&dex |
Primary outcome
evaluate the first call for rescue analgesia
Time frame: 24 hours after recovery from anesthesia
the time of the first call for analgesia is recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Cholecystitis and Appendicitis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the first call for rescue analgesia (time frame: 24 hours after recovery from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.