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

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04732234

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Superior Hypogastric Plexus Block	N/A

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%

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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%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:

Double (Participant, Investigator)

Masking Description:

Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ( Group A) ultrasound guided superior hypogastric plexus block using 20 ml Bupivacaine 0.5% before skin incision.	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
Placebo Comparator: (Group B) ultrasound guided superior hypogastric plexus block using 20 ml normal saline 0.9% instead of bupivacaine.	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

Arm

Intervention/Treatment

Active Comparator: ( Group A)

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

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

Placebo Comparator: (Group B)

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

Procedure: Superior Hypogastric Plexus Block

Outcome Measures

Primary Outcome Measures

morphine consumption [baseline till 24 hours postoperative]
Total 24 hours morphine consumption in milligrams

Secondary Outcome Measures

Visual analogue scale (VAS) [Visual analogue scale (VAS) at baseline till 24 hours postoperative]
scale in which 0 is least pain and 10 is sever pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA II,III.
Patients undergoing pelvic surgeries.

Exclusion Criteria:

Patients refusal,
Coagulopathy,
Infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nataional Cancer Instituite	Cairo		Egypt

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

Principal Investigator: Mohamed abdel wadod, MD, Anesthesia & pain management Dept, National Cancer Institute-Cairo - Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Abdelfattah Abdelwadod, Mohammed Abdelfattah Abdelwadod, National Cancer Institute, Egypt

ClinicalTrials.gov Identifier:

NCT04732234

Other Study ID Numbers:

IORG0003381-AP2006-50103

First Posted:

Feb 1, 2021

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pelvic Neoplasms

Study Results

No Results Posted as of Feb 1, 2021