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

NCT04732234 | Unknown

• 1 other identifier: IORG0003381-AP2006-50103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  Total 24 hours morphine consumption in milligrams

  baseline till 24 hours postoperative

Secondary Outcomes (1)

• Visual analogue scale (VAS)

  Visual analogue scale (VAS) at baseline till 24 hours postoperative

Study Arms (2)

( Group A)

ACTIVE COMPARATOR

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

Procedure: Superior Hypogastric Plexus Block

(Group B)

PLACEBO COMPARATOR

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

Procedure: Superior Hypogastric Plexus Block

Interventions

Superior Hypogastric Plexus Block 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 A); (Group B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients refusal,
• Coagulopathy,
• Infection.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Nataional Cancer Instituite

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed abdel wadod, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohammed Abdelfattah Abdelwadod

Model Details: 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%

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: February 1, 2021
• Study Start: December 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

EG (1)