- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07590752
"Dexa vs Dexmedetomidine With Bupivacaine in TAP Block for Laparotomy Analgesia
Comparison Of Dexamethasone Versus Dexmedetomidine As An Adjuvant To 0.25% Bupivacaine In Ultrasound Guided Tap Block On Post-Op Analgesia Duration In Patients Undergoing Laparotomy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
After approval of synopsis by the research board and ethical committee and Research department CPSP Karachi, the data collection process will begin. The study will be conducted in the Anesthesia Department of Sahiwal Teaching Hospital Sahiwal. Written informed consent will be obtained from all the patients included in the study. Patients aged between 25 to 65 years, belonging to ASA class-I and class-II, scheduled for laparotomy will be divided into 2 groups of 48 patients each:
- Group A: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2 ml Dexamethasone 8mg.
- Group B: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2ml Dexmedetomidine (1µg/Kg diluted in 2ml saline).
At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation. Patients will be observed for any complication like signs of local anesthetic toxicity or hematoma formation at site of block. In PACU and surgical unit, Visual Analogue Scale Score (VAS) will be recorded at arrival to PACU 2, 4, 6, 12 and 24 hours post-operative. A VAS score of ≤3 will be considered satisfactory pain relief. If patients have inadequate analgesia, supplementary rescue analgesia will be given in the form of IV ketorolac 30mg at VAS ≥4. The time of first request for rescue analgesic will be recorded. Post-operative nausea and vomiting will be documented according to a categorical scale: 0 none, 1 nausea, 2 vomiting, 3 nausea and vomiting. Hemodynamic variables such as heart rate and mean arterial pressure will be recorded. The primary outcome will be to compare the time for first rescue analgesia. The secondary outcome will be assessment of postoperative pain using VAS score at 2, 6, 12, 18 and 24 hrs.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Dr Maryam Mumtaz, MBBS
- Telefonnummer: 00923336238201
- E-mail: Maryamsumra3@gmail.com
Undersøgelse Kontakt Backup
- Navn: Dr Muhammad Shahid
- Telefonnummer: 00923336173056
- E-mail: shahidnishtar@gmail.com
Studiesteder
-
-
Punjab Province
-
Sahiwal, Punjab Province, Pakistan, 57000
- Rekruttering
- Sahiwal Medical College
-
Kontakt:
- Dr Rao Riaz ul Haq, FCPS
- Telefonnummer: 009240452470
- E-mail: slmcswl@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients undergoing laparotomy.
- Patients aged 25 to 65 years.
- Both genders.
- Patients with ASA Class I, II.
Exclusion Criteria:
- Patients who do not give consent.
- Patients with Comorbidities like DM, HTN, CKD, CLD.
- Patients with bleeding disorders.
- Infection at site of injection.
- Allergy to any drug, local anaesthetic, or other drugs used.
- Patients with polytrauma.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: GROUP A
GROUP BUPIVACAINE+DEXAMETHASONE
|
At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed using ultrasound machine.
The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line.
The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles.
Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.
Andre navne:
|
|
Andet: GROUP B
GROUP BUPIVACAINE+DEXAMETHASONE+DEXMEDETOMIDINE
|
At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine.
The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line.
The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles.
Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
postoperative pain
Tidsramme: 24 hours
|
Duration of postop analgesia
|
24 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Adeel Riaz, MD, Sahiwal medical college sahiwal
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 161/IRB/SLMC/SWL
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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