Spinal AnaesthesiaNCT06703229
Assessment of the Impact of Two Dexmedetomidine Dosages Added with Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Inguinal Hernia Repair
A study testing The Transversus Abdominis Plane (TAP) block and The transverse abdominis plane (TAP) block in people with Spinal Anaesthesia and Herniorrhaphy, run by Helwan University at 1 site in Egypt.
Trial summary
The principal outcome assessed was the duration until the initial request for analgesia post-surgery. The secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Anaesthesia, Herniorrhaphy, Transversus Abdominis Plane Block
- What is being tested?
- The Transversus Abdominis Plane (TAP) block and The transverse abdominis plane (TAP) block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 Nov 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with ASA physical status I or II
- scheduled for elective unilateral inguinal hernioplasty under spinal anesthesia
- aged 18 to 60 years
- both genders
Who cannot join
- patient refusal, BMI ≥ 40 kg/m2 incapacity to engage in pain assessment contraindications to spinal anesthesia (e.g., coagulopathy, skin infection)
- and intolerance to the research medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of Two Dexmedetomidine Dosages Added with Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Inguinal Hernia Repair: Randomized Controlled Study
The principal outcome assessed was the duration until the initial request for analgesia post-surgery. The secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. Pain levels, measured using the Visual Analogue Scale (VAS), were evaluated at rest and during movement at many intervals following surgery (1, 6, 12, and 24 hours). The study also observed postoperative complications, such as emesis, hypotension, bradycardia, and pruritus.
Read the detailed description
One of the most frequently performed surgical procedures worldwide is the repair of an open inguinal hernia, with a postoperative pain severity of moderate to severe affecting over 60% of patients. Post-surgical analgesia frequently employs a multifaceted approach, incorporating oral pharmacotherapy and regional anesthetic procedures. Opioids are a conventional option for postoperative pain management; nevertheless, their administration is linked to adverse effects such as nausea, vomiting, sleepiness, pruritus, and respiratory depression, which may impede the recovery process. Non-opioid alternatives, however, can improve patient rehabilitation and overall outcomes. The Transversus Abdominis Plane (TAP) block efficiently reduces early postoperative discomfort and decreases narcotic usage, which is a significant advantage for patients undergoing inguinal hernia repair. To alleviate pain in the abdominal wall muscles, peritoneum, and skin, this treatment involves administering a local anesthetic into the space between the transversus abdominis and internal oblique muscles.]2[
- Being tested
- The Transversus Abdominis Plane (TAP) block, The transverse abdominis plane (TAP) block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Transversus Abdominis Plane (TAP) blockDrug
or injectate preparation, utilizing ultrasound guidance while the patient was supine. In the D1 group, patients were administered 20 mL of 0.25% isobaric bupivacaine with 0.5 mcg/kg of dexmedetomidine.
The transverse abdominis plane (TAP) blockDrug
Patients in the D2 group received 20 mL of 0.25% isobaric bupivacaine with 1 mcg/kg of dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| group, D1 | Active comparator | group, D1, had a TAP block that included 0.5 µg/kg of dexmedetomidine and bupivacaine Receives: Drug: The Transversus Abdominis Plane (TAP) block |
| group, D2 | Active comparator | group, D2, received the same block but with 1 µg/kg of dexmedetomidine. Receives: Drug: The transverse abdominis plane (TAP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the initial request for analgesia post-surgery
The postoperative Visual Analogue Scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Jan 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnaesthesiaStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ali Hassan, Port Said University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703229
- Sponsor's protocol ID
- CT2023-010
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Two Dexmedetomidine Dosages Added with Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Inguinal Hernia Repair: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06703229
- Acronym / sponsor ID
- CT2023-010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 25 Nov 2024 (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 principal outcome assessed was the duration until the initial request for analgesia post-surgery. The secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. Pain levels, measured using the Visual Analogue Scale (VAS), were evaluated at rest and during movement at many intervals following surgery (1, 6, 12, and 24 hours). The study also observed postoperative complications, such as emesis, hypotension, bradycardia, and pruritus.
Detailed description
One of the most frequently performed surgical procedures worldwide is the repair of an open inguinal hernia, with a postoperative pain severity of moderate to severe affecting over 60% of patients. Post-surgical analgesia frequently employs a multifaceted approach, incorporating oral pharmacotherapy and regional anesthetic procedures. Opioids are a conventional option for postoperative pain management; nevertheless, their administration is linked to adverse effects such as nausea, vomiting, sleepiness, pruritus, and respiratory depression, which may impede the recovery process. Non-opioid alternatives, however, can improve patient rehabilitation and overall outcomes. The Transversus Abdominis Plane (TAP) block efficiently reduces early postoperative discomfort and decreases narcotic usage, which is a significant advantage for patients undergoing inguinal hernia repair. To alleviate pain in the abdominal wall muscles, peritoneum, and skin, this treatment involves administering a local anesthetic into the space between the transversus abdominis and internal oblique muscles.]2[
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group, D1 | Active comparator | Drug: The Transversus Abdominis Plane (TAP) blockgroup, D1, had a TAP block that included 0.5 µg/kg of dexmedetomidine and bupivacaine |
| group, D2 | Active comparator | Drug: The transverse abdominis plane (TAP) blockgroup, D2, received the same block but with 1 µg/kg of dexmedetomidine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- with ASA physical status I or II
- scheduled for elective unilateral inguinal hernioplasty under spinal anesthesia
- aged 18 to 60 years
- both genders
Key exclusion criteria (2 listed)
- patient refusal, BMI ≥ 40 kg/m2 incapacity to engage in pain assessment contraindications to spinal anesthesia (e.g., coagulopathy, skin infection)
- and intolerance to the research medications.
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 |
|---|---|---|
| The Transversus Abdominis Plane (TAP) blockor injectate preparation, utilizing ultrasound guidance while the patient was supine. In the D1 group, patients were administered 20 mL of 0.25% isobaric bupivacaine with 0.5 mcg/kg of dexmedetomidine. | Drug | group, D1 |
| The transverse abdominis plane (TAP) blockPatients in the D2 group received 20 mL of 0.25% isobaric bupivacaine with 1 mcg/kg of dexmedetomidine. | Drug | group, D2 |
Primary outcome
the initial request for analgesia post-surgery
Time frame: 24 hours
The postoperative Visual Analogue Scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.
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 10 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 The Transversus Abdominis Plane (TAP) block and The transverse abdominis plane (TAP) block in people with Spinal Anaesthesia and Herniorrhaphy, run by Helwan 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 2 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 10 Dec 2024. 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. 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?
the initial request for analgesia post-surgery (time frame: 24 hours). 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 10 Dec 2024.