NCT05301634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 2, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 30, 2025

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

March 20, 2022

Last Update Submit

December 23, 2025

Conditions

Intraoperative Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean arterial blood pressure

    at the time of mucosal dissection

Secondary Outcomes (5)

  • Intraoperative need for magnesium sulphate

    the entire duration of surgery

  • Intraoperative need for fentanyl

    the entire duration of surgery

  • Intraoperative need for nitroglycerine

    the entire duration of surgery

  • Postoperative need of pethidine

    24 hours postoprative

  • Postoperative pain assessed by Numeric pain score

    24 hours postoprative

Study Arms (2)

Group A

ACTIVE COMPARATOR

the patients will receive bilateral infraorbital block

Procedure: infraorbital block

Group B

ACTIVE COMPARATOR

the patients will receive topical intranasal application of bupivacaine

Procedure: topical intranasal bupivacaine

Interventions

infraorbital blockPROCEDURE

the patients will receive bilateral infraorbital block

Group A
topical intranasal bupivacainePROCEDURE

the patients will receive topical intranasal application of bupivacaine

Group B

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anaesthesia

Study Record Dates

First Submitted

March 20, 2022

First Posted

March 31, 2022

Study Start

April 2, 2022

Primary Completion

July 30, 2025

Study Completion

December 15, 2025

Last Updated

December 30, 2025

Record last verified: 2022-05

Locations

EG(1)