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Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection

Primary Purpose

Intraoperative Hypertension

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

infraorbital block

topical intranasal bupivacaine

About this trial

This is an interventional treatment trial for Intraoperative Hypertension

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I, II or III
patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia

Exclusion Criteria:

Patient's refusal
Allergy to local anesthetics.
Preoperative cerebrospinal fluid leak.
Preoperative cardiac arrythmias.
Seizure disorders.
Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.

Sites / Locations

Kasr Alaini hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

the patients will receive bilateral infraorbital block

the patients will receive topical intranasal application of bupivacaine

Outcomes

Primary Outcome Measures

Mean arterial blood pressure

Secondary Outcome Measures

Intraoperative need for magnesium sulphate

Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline

Intraoperative need for fentanyl

Intraoperative need for iv fentanyl blouses 0.5 μg/kg (maximum total dose 5 μg/kg for the entire procedure) if no response to magnesium sulphate

Intraoperative need for nitroglycerine

Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl

Postoperative need of pethidine

Postoperative need of pethidine boluses 25 mg with max.100 mg

Postoperative pain assessed by Numeric pain score

Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale [NRS] 0-100; 0 = Non ,100 = Worst imaginable pain)

Full Information

NCT ID

NCT05301634

First Posted

March 20, 2022

Last Updated

May 23, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05301634

Brief Title

Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection

Official Title

Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 2, 2022 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intraoperative Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

the patients will receive bilateral infraorbital block

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

the patients will receive topical intranasal application of bupivacaine

Intervention Type

Procedure

Intervention Name(s)

infraorbital block

Intervention Description

the patients will receive bilateral infraorbital block

Intervention Type

Procedure

Intervention Name(s)

topical intranasal bupivacaine

Intervention Description

the patients will receive topical intranasal application of bupivacaine

Primary Outcome Measure Information:

Title

Mean arterial blood pressure

Time Frame

at the time of mucosal dissection

Secondary Outcome Measure Information:

Title

Intraoperative need for magnesium sulphate

Description

Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline

Time Frame

the entire duration of surgery

Title

Intraoperative need for fentanyl

Description

Intraoperative need for iv fentanyl blouses 0.5 μg/kg (maximum total dose 5 μg/kg for the entire procedure) if no response to magnesium sulphate

Time Frame

the entire duration of surgery

Title

Intraoperative need for nitroglycerine

Description

Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl

Time Frame

the entire duration of surgery

Title

Postoperative need of pethidine

Description

Postoperative need of pethidine boluses 25 mg with max.100 mg

Time Frame

24 hours postoprative

Title

Postoperative pain assessed by Numeric pain score

Description

Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale [NRS] 0-100; 0 = Non ,100 = Worst imaginable pain)

Time Frame

24 hours postoprative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I, II or III patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia Exclusion Criteria: Patient's refusal Allergy to local anesthetics. Preoperative cerebrospinal fluid leak. Preoperative cardiac arrythmias. Seizure disorders. Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.

Facility Information:

Facility Name

Kasr Alaini hospital

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

abdelkhalek m Samy

Phone

01025854248

dr.abdo86@gmail.com

First Name & Middle Initial & Last Name & Degree

Eman M Mahmoud

First Name & Middle Initial & Last Name & Degree

Khaled EL Elshafei

First Name & Middle Initial & Last Name & Degree

Mohamed F Elmahdy

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection

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