Local AnestheticNCT06131593
TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures
A study testing TAPB with dexamethasone as an adjuvant to local anesthetics and TAPB with methylprednisolone as an adjuvant to local anesthetics in people with Local Anesthetic and Ultrasound, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Local Anesthetic, Ultrasound, Pain, Acute
- What is being tested?
- TAPB with dexamethasone as an adjuvant to local anesthetics and TAPB with methylprednisolone as an adjuvant to local anesthetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 20 Apr 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II.
- Age 20-45 years.
- Undergoing lower abdominal hysterectomies.
Who cannot join
- Patient refusal
- Patients with coagulopathy.
- Hypertensive patients.
- Diabetic patients.
- Morbid obesity
- Allergy to the used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TAP Block With Dexamethasone Versus TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures: Randomized Controlled Trial
The aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures.
Read the detailed description
Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).
By the end of surgery and with the patient in supine position and after covering of surgery site, preparing the skin with povidone iodine, a high frequency (5-10 MHZ) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest, then 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 8mg dexamethasone in group A patients and 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 50 mg methylprednisolone in group B patients.
Vital signs (H.R and non invasive blood pressure) will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs. post operative
Postoperative:
Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes
Post-operative assessment and analgesic regimen
Post operative pain assessment using V.A.S will be assessed (0-10) (11) (as zero refer to no pain and 10 refer to the worst pain) after 1h of the block then every 4hrs for 12 hrs. then every 8hrs for 48 hrs then after 72hrs . The patient will be given Paracetamol every 8 hours and ketorolac every 12 hours The time to the first request of rescue post operative analgesic will be recorded, when the patient complain of pain (V.A.S> 3) intravenous nalbuphine 5mg will be given, total dose of nalbuphine will be recorded /24hrs.
- Conditions
- Local Anesthetic, Ultrasound, Pain, Acute
- Being tested
- TAPB with dexamethasone as an adjuvant to local anesthetics, TAPB with methylprednisolone as an adjuvant to local anesthetics
- Keywords
- ultrasound, TAP block, Hystrectomy, methyl prednisolone
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPB with dexamethasone as an adjuvant to local anestheticsDrug
patients will receive TAPB with dexamethasone as an adjuvant to bupivacaine and lidocaine local anesthetics
TAPB with methylprednisolone as an adjuvant to local anestheticsDrug
patients will receive TAPB with methylprednisolone as an adjuvant to bupivacaine and lidocaine local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Group TAPB-D (n=25) | Experimental | Patients in this group will receive TAPB with dexamethasone as an adjuvant to local anesthetic. Receives: Drug: TAPB with dexamethasone as an adjuvant to local anesthetics |
| Group TAPB-M (n=25) | Active comparator | Patients in this group will receive TAPB with methylprednisolone as an adjuvant to local anesthetic. Receives: Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score by Visual analogue score at 48 hrs.
postoperative pain score by Visual analogue score at 48 hours Post operative pain assessment using Visual analogue score which is numerical score from (0-10) (zero refer to no pain and 10 refer to the worst pain)
Measured: 48 hours
Secondary outcomes (2)
Time to first analgesic request of rescue analgesia
Time to first analgesic request of nalbuphine as a rescue analgesia
Measured: 24 hours
Total consumption of Nalbuphine in 1st 24 hours
Total consumption of Nalbuphine in 1st 24 hours
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 posted14 Nov 2023
- Study start1 Dec 2023
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnestheticStudies 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
- Model description
- Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131593
- Sponsor's protocol ID
- N-139-2023
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP Block With Dexamethasone Versus TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06131593
- Acronym / sponsor ID
- N-139-2023
- Conditions
- Local Anesthetic, Ultrasound, Pain, Acute
- Keywords
- ultrasound, TAP block, Hystrectomy, methyl prednisolone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 14 Nov 2023 (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 aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures.
Detailed description
Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).
By the end of surgery and with the patient in supine position and after covering of surgery site, preparing the skin with povidone iodine, a high frequency (5-10 MHZ) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest, then 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 8mg dexamethasone in group A patients and 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 50 mg methylprednisolone in group B patients.
Vital signs (H.R and non invasive blood pressure) will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs. post operative
Postoperative:
Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes
Post-operative assessment and analgesic regimen
Post operative pain assessment using V.A.S will be assessed (0-10) (11) (as zero refer to no pain and 10 refer to the worst pain) after 1h of the block then every 4hrs for 12 hrs. then every 8hrs for 48 hrs then after 72hrs . The patient will be given Paracetamol every 8 hours and ketorolac every 12 hours The time to the first request of rescue post operative analgesic will be recorded, when the patient complain of pain (V.A.S> 3) intravenous nalbuphine 5mg will be given, total dose of nalbuphine will be recorded /24hrs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).
| Arm | Type | Receives |
|---|---|---|
| Group TAPB-D (n=25) | Experimental | Drug: TAPB with dexamethasone as an adjuvant to local anestheticsPatients in this group will receive TAPB with dexamethasone as an adjuvant to local anesthetic. |
| Group TAPB-M (n=25) | Active comparator | Drug: TAPB with methylprednisolone as an adjuvant to local anestheticsPatients in this group will receive TAPB with methylprednisolone as an adjuvant to local anesthetic. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I-II.
- Age 20-45 years.
- Undergoing lower abdominal hysterectomies.
Key exclusion criteria (6 listed)
- Patient refusal
- Patients with coagulopathy.
- Hypertensive patients.
- Diabetic patients.
- Morbid obesity
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 |
|---|---|---|
| TAPB with dexamethasone as an adjuvant to local anestheticspatients will receive TAPB with dexamethasone as an adjuvant to bupivacaine and lidocaine local anesthetics | Drug | Group TAPB-D (n=25) |
| TAPB with methylprednisolone as an adjuvant to local anestheticspatients will receive TAPB with methylprednisolone as an adjuvant to bupivacaine and lidocaine local anesthetics | Drug | Group TAPB-M (n=25) |
Primary outcome
postoperative pain score by Visual analogue score at 48 hrs.
Time frame: 48 hours
postoperative pain score by Visual analogue score at 48 hours Post operative pain assessment using Visual analogue score which is numerical score from (0-10) (zero refer to no pain and 10 refer to the worst pain)
2 secondary outcomes
Time to first analgesic request of rescue analgesia
Time frame: 24 hours
Total consumption of Nalbuphine in 1st 24 hours
Time frame: 24 hours
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 23 Apr 2024.
- Individual participant dataSharing planned: No
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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 TAPB with dexamethasone as an adjuvant to local anesthetics and TAPB with methylprednisolone as an adjuvant to local anesthetics in people with Local Anesthetic and Ultrasound, run by Kasr El Aini Hospital 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 3 inclusion and 6 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 23 Apr 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?
postoperative pain score by Visual analogue score at 48 hrs. (time frame: 48 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 23 Apr 2024.