Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study

NCT ID: NCT04732234

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-31

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%

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

( Group A)

ultrasound guided superior hypogastric plexus block using 20 ml Bupivacaine 0.5% before skin incision.

Group Type: ACTIVE_COMPARATOR

Superior Hypogastric Plexus Block

Intervention Type: PROCEDURE

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

(Group B)

ultrasound guided superior hypogastric plexus block using 20 ml normal saline 0.9% instead of bupivacaine.

Group Type: PLACEBO_COMPARATOR

Superior Hypogastric Plexus Block

Intervention Type: PROCEDURE

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

Interventions

Superior Hypogastric Plexus Block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA II,III.
• Patients undergoing pelvic surgeries.

Exclusion Criteria

• Patients refusal,
• Coagulopathy,
• Infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abdelfattah Abdelwadod

Mohammed Abdelfattah Abdelwadod

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed abdel wadod, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia & pain management Dept, National Cancer Institute-Cairo - Egypt

Locations

Nataional Cancer Instituite

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IORG0003381-AP2006-50103

Identifier Type: -

Identifier Source: org_study_id