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Clinical Trials/NCT04732234
NCT04732234UnknownNot Applicable

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

National Cancer Institute, Egypt1 site in 1 country40 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
morphine consumption

Study Overview

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%

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Patients refusal,
  • Coagulopathy,
  • Infection.

Outcomes

Primary Outcomes

morphine consumption

Time Frame: baseline till 24 hours postoperative

Total 24 hours morphine consumption in milligrams

Secondary Outcomes

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

Investigators

Sponsor
National Cancer Institute, Egypt
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Abdelfattah Abdelwadod

Mohammed Abdelfattah Abdelwadod

National Cancer Institute, Egypt

Study Sites (1)

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