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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04732234
• Other study ID #: IORG0003381-AP2006-50103
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 2021

Study information

• Verified date: January 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA II,III.

• Patients undergoing pelvic surgeries.

Exclusion Criteria:

• Patients refusal,

• Coagulopathy,

• Infection.

Related Conditions & MeSH terms

• Analgesia
• Pelvic Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Nataional Cancer Instituite	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	Total 24 hours morphine consumption in milligrams	baseline till 24 hours postoperative
Secondary	Visual analogue scale (VAS)	scale in which 0 is least pain and 10 is sever pain	Visual analogue scale (VAS) at baseline till 24 hours postoperative