Back to resultsPre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
Primary Purpose
Analgesia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Superior Hypogastric Plexus Block
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- ASA II,III.
- Patients undergoing pelvic surgeries.
Exclusion Criteria:
- Patients refusal,
- Coagulopathy,
- Infection.
Sites / Locations
- Nataional Cancer Instituite
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
( Group A)
(Group B)
Arm Description
ultrasound guided superior hypogastric plexus block using 20 ml Bupivacaine 0.5% before skin incision.
ultrasound guided superior hypogastric plexus block using 20 ml normal saline 0.9% instead of bupivacaine.
Outcomes
Primary Outcome Measures
morphine consumption
Total 24 hours morphine consumption in milligrams
Secondary Outcome Measures
Visual analogue scale (VAS)
scale in which 0 is least pain and 10 is sever pain
Full Information
NCT ID
NCT04732234
First Posted
December 25, 2020
Last Updated
January 26, 2021
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04732234
Brief Title
Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
Official Title
Pre-emptive Ultrasound Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The superior hypogastric plexus (SHP) is a retroperitoneal structure with a predominance of afferent sympathetic nerve fibers. The perception of central pelvic pain is thought mainly to involve transmission through this plexus. Therefore, blocking or of SHP has been used to treat pelvic pain.
Detailed Description
Ultrasound guided superior hypogastric plexus block there is 2 equal groups:
Group S (SHPB group 18 patients) ultrasound guided SHPB is done after induction of balanced general anesthesia (fentanyl, propofol and rocuronium) using 20 ml Bupivacaine 0.5% before skin incision, Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9% instead of bupivacaine. Patients of both groups will receive patient controlled analgesia using morphine with continous background infusion of morphine 1.5 mg/h with adding granisterone 2mg/60 ml and ability to give bolus of 0.5 mg morphine on demand.
• Dosing and administration; Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.
Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.
Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%
Masking
ParticipantInvestigator
Masking Description
Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
( Group A)
Arm Type
Active Comparator
Arm Description
ultrasound guided superior hypogastric plexus block using 20 ml Bupivacaine 0.5% before skin incision.
Arm Title
(Group B)
Arm Type
Placebo Comparator
Arm Description
ultrasound guided superior hypogastric plexus block using 20 ml normal saline 0.9% instead of bupivacaine.
Intervention Type
Procedure
Intervention Name(s)
Superior Hypogastric Plexus Block
Intervention Description
Pre operative ultrasound guided superior hypogastric plexus block in pelvic surgeries using a curvilinear probe below umbalicus with needle in plane technique to reach the plexus in front of L5 vertebra
Primary Outcome Measure Information:
Title
morphine consumption
Description
Total 24 hours morphine consumption in milligrams
Time Frame
baseline till 24 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
scale in which 0 is least pain and 10 is sever pain
Time Frame
Visual analogue scale (VAS) at baseline till 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA II,III.
Patients undergoing pelvic surgeries.
Exclusion Criteria:
Patients refusal,
Coagulopathy,
Infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed abdel wadod, MD
Organizational Affiliation
Anesthesia & pain management Dept, National Cancer Institute-Cairo - Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nataional Cancer Instituite
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
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