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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05323565
Other study ID # FMASU M D 184/2020
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2022
Est. completion date July 5, 2022

Study information

Verified date April 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.


Description:

A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date July 5, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2. Exclusion Criteria: - Infection at site of injection. - Patient refusal. - Psychiatric or physical illness that lead to inability to cooperate, speak or read. - Abdominal operations under spinal anesthesia. - History or evidence of coagulopathy. - Known allergies to drugs used . - Preexisting neurological disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
adjuvants to 0.25 bupivacaine in TAB block.

Locations

Country Name City State
Egypt Ain Shams University, Faculty of medicine Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1st time for rescue analgesia Time to first analgesia requirment(starting from drug injection) first 24 hours post-operatively
Secondary Pain score- Visual Analogue Score (VAS) It ranges from 0 indicating no pain till 10 indicating severe intolerable pain with variable degrees of ascending pain in between] was assessed at 0 min (AT PACU), 2hr,6 hr, 12 hr, 18 hr, and 24 hr postoperatively. First 24 hours post-operatively.
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