Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316908
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2024-01-21
Brief Title:
Permanent Celiac Plexus Block Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
Sponsor:
Sindh Institute of Urology and Transplantation
Organization:
Sindh Institute of Urology and Transplantation
Study Overview
Official Title:
Permanent Celiac Plexus Block Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this prospective interventional non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block NCPB in upper abdominal cancer patients
The main questions it aimed to answer are
1 Whether unilateral or bilateral NCPB technique has a better pain relief
2 Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block
Pain scores and adverse events at multiple time points post-procedure were recorded
The main questions it aimed to answer are
1 Whether unilateral or bilateral NCPB technique has a better pain relief
2 Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block
Pain scores and adverse events at multiple time points post-procedure were recorded
Detailed Description:
After Institutional Research Committee clearance and Ethical Review Committee approval from the Sindh Institute of Urology Transplantation the patients were divided into two groups 15 patients in each group Forty milliliters of the study drug were prepared in a 50 milliliters mL syringe by a pharmacy person Patients were nil per oral NPO for six hours and after a written informed consent patients were brought in the operating room A 20-gauge G intravenous IV cannula was passed and started injection ringer lactate at 10 mLkg body weight for all patients except diabetic mellitus who received normal saline Monitors were applied as per American Society of Anesthesiologist ASA standards ie electrocardiogram ECG oxygen saturation SpO2 and non-invasive blood pressure NIBP and vitals were recorded at intervals of 5 minutes min Patients were then positioned prone on the operation table and their arms were rested on the arm board Pillows were placed under the abdomen between the ribs and iliac crest
First a mark was made between the 12 Thoracic T12 and 1st Lumbar L1 vertebra under the Fluoroscopic C arm view Then a line was drawn between the points at 5 and 7 cm lateral from the spinous process of the L3 vertebra Injection 2 plain xylocaine 3-5 milliliters mL was locally infiltrated and a 20-centimeter cm 22gauge G Chiba needle was inserted at an angle of 45 degrees with the skin and directed medially and in cephalic direction After making contact with the body of the L1 vertebra needle was withdrawn and reinserted with an increased angle between the needle shaft and the skin until the tip of the needle slipped off the body of the L1 vertebra Then the needle was advanced 1-15 cm in front of the T12 L1 vertebrae The position of the needle was confirmed in the anterior and lateral views of the vertebra with the help of radiopaque dye under a fluoroscopic C arm view After the proper confirmation of the tip of the needle 40 mL of absolute alcohol was injected into the unilateral block Whereas in the bilateral technique 20 mL absolute alcohol on both sides were injected During and after the drug administration the pattern of the drug distribution was observed very carefully anterior to the body of the L1 vertebra and psoas fascia and any visceral and IV drug administration was avoided After alcohol administration 025 Bupivacaine 5 mL was given and then withdrawn the needle The patient remained in the prone position for 20 mins After the patients were turned supine and shifted to the post-anesthesia care unit PACU for monitoring of vitals for 30 mins after which they shifted to the ward Pain score was recorded immediately and then at 30 mins in PACU then at 6 12 and 24 hours Patients were discharged after 24 hours or when stable pain score was recorded on telephonic conversation outpatient clinic visits at 7 days 1 month 3 months and 6 months after the procedure or till death if the patient expired before 6 months
First a mark was made between the 12 Thoracic T12 and 1st Lumbar L1 vertebra under the Fluoroscopic C arm view Then a line was drawn between the points at 5 and 7 cm lateral from the spinous process of the L3 vertebra Injection 2 plain xylocaine 3-5 milliliters mL was locally infiltrated and a 20-centimeter cm 22gauge G Chiba needle was inserted at an angle of 45 degrees with the skin and directed medially and in cephalic direction After making contact with the body of the L1 vertebra needle was withdrawn and reinserted with an increased angle between the needle shaft and the skin until the tip of the needle slipped off the body of the L1 vertebra Then the needle was advanced 1-15 cm in front of the T12 L1 vertebrae The position of the needle was confirmed in the anterior and lateral views of the vertebra with the help of radiopaque dye under a fluoroscopic C arm view After the proper confirmation of the tip of the needle 40 mL of absolute alcohol was injected into the unilateral block Whereas in the bilateral technique 20 mL absolute alcohol on both sides were injected During and after the drug administration the pattern of the drug distribution was observed very carefully anterior to the body of the L1 vertebra and psoas fascia and any visceral and IV drug administration was avoided After alcohol administration 025 Bupivacaine 5 mL was given and then withdrawn the needle The patient remained in the prone position for 20 mins After the patients were turned supine and shifted to the post-anesthesia care unit PACU for monitoring of vitals for 30 mins after which they shifted to the ward Pain score was recorded immediately and then at 30 mins in PACU then at 6 12 and 24 hours Patients were discharged after 24 hours or when stable pain score was recorded on telephonic conversation outpatient clinic visits at 7 days 1 month 3 months and 6 months after the procedure or till death if the patient expired before 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None