Sahiwal Medical College
Sahiwal, Punjab Province, 57000, Pakistan
Location status: Recruiting
NCT Number: NCT07590752
Transversus abdominis plane block is a regional anesthetic technique which blocks the abdominal neural afferents by introducing local anesthetic into the neuro-fascial plane between the internal oblique and the transversus abdominis muscle and gives analgesia from the skin to parietal peritoneum. There are studies showing evidence of improved post operative analgesia with addition of adjuvants such as dexmedetomidine or dexamethasone in comparison with plane local anesthesia in terms of time to rescue analgesia and the overall quantity of analgesic used post operatively.
Interested in participating?
Request Info25 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Sahiwal, Punjab Province, 57000, Pakistan
Location status: Recruiting
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Bupivacaine+Dexamethasone
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.
Other names: Bupivacaine+ Dexamethasone +Dexmedetomidine
Time frame: 24 hours
Duration of postop analgesia
Contact information is provided by the study sponsor or research team.
Dr Maryam Mumtaz, MBBS
CONTACT
Dr Muhammad Shahid
CONTACT
Sahiwal medical college sahiwal
Other Gov
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
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