The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Period of Hypophysectomy

NCT05555147 | Unknown DMC

• 1 other identifier: TJ2012S152
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain which is difficult to suppress at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can provide stable hemodynamics and reduce the hemodynamic fluctuation the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear.

Conditions

Pain; Nerve Block

Outcome Measures

Primary Outcomes (24)

• mean arterial pressure (MAP) before nerve block

  mean arterial pressure (MAP) before nerve block

  before nerve block

• heat rate (HR) before nerve block

  heat rate (HR) before nerve block

  before nerve block

• MAP within 10 minutes after nerve block

  MAP within 10 minutes after nerve block

  within 10 minutes after nerve block

• HR within 10 minutes after nerve block

  HR within 10 minutes after nerve block

  within 10 minutes after nerve block

• MAP before nasal mucosal dissection

  MAP before nasal mucosal dissection

  before nasal mucosal dissection

• HR before nasal mucosal dissection

  HR before nasal mucosal dissection

  before nasal mucosal dissection

• MAP immediately after nasal mucosal dissection

  MAP immediately after nasal mucosal dissection

  immediately after nasal mucosal dissection

• HR immediately after nasal mucosal dissection

  HR immediately after nasal mucosal dissection

  immediately after nasal mucosal dissection

• MAP before septum resection

  MAP before septum resection

  before septum resection

• HR before septum resection

  HR before septum resection

  before septum resection

• MAP immediately after septum resection

  MAP immediately after septum resection

  immediately after septum resection

• HR immediately after septum resection

  HR immediately after septum resection

  immediately after septum resection

• MAP before sella bone resection

  MAP before sella bone resection

  before sella bone resection

• HR before sella bone resection

  HR before sella bone resection

  before sella bone resection

• MAP after sella bone resection

  MAP after sella bone resection

  before sella bone resection

• HR immediately after sella bone resection

  HR immediately after sella bone resection

  immediately after sella bone resection

• MAP before dural incision of sella

  MAP before dural incision of sella

  before dural incision of sella

• HR before dural incision of sella

  HR before dural incision of sella

  before dural incision of sella

• MAP immediately after dural incision of sella

  MAP immediately after dural incision of sella

  immediately after dural incision of sella

• HR immediately after dural incision of sella

  HR immediately after dural incision of sella

  immediately after dural incision of sella

• MAP before exploration of pituitary fossa

  MAP before exploration of pituitary fossa

  before exploration of pituitary fossa

• HR before exploration of pituitary fossa

  HR before exploration of pituitary fossa

  before exploration of pituitary fossa

• MAP immediately after exploration of pituitary fossa

  MAP immediately after exploration of pituitary fossa

  immediately after exploration of pituitary fossa

• HR immediately after exploration of pituitary fossa

  HR immediately after exploration of pituitary fossa

  immediately after exploration of pituitary fossa

Secondary Outcomes (9)

• numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)

  when patient enters PACU (immediately after surgery)

• numerical rating scale (NRS) score before patient leaves PACU

  before patient leaves PACU

• NRS 2 hours after surgery

  2 hours after surgery

• NRS 8 hours after surgery

  8 hours after surgery

• NRS 24 hours after surgery

  24 hours after surgery

Other Outcomes (24)

• incidence of postoperative nausea and vomiting (PONV) within 24 hours

  within 24h after surgery

• incidence of postoperative nausea and vomiting (PONV) within 48 hours

  within 48 hours after surgery

• Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery)

  when patient enters PACU (immediately after surgery)

Study Arms (2)

Nerve Block Group

EXPERIMENTAL

Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. Infraorbital nerve block was performed while using an extraoral approach. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 mL of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner.

Drug: nerve block with 0.5% ropivacaine

Control Group

SHAM COMPARATOR

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Other: without any nerve block

Interventions

nerve block with 0.5% ropivacaine DRUG

After general anesthesia, the patients will receive bilateral infraorbital and infratrochlear nerve block 30 minutes prior to surgery. Infraorbital nerve block is performed while using an extraoral approach. A 25-gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 ml of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed infratrochlear nerve block. After negative aspiration of blood, 1 ml of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner.

Nerve Block Group

without any nerve block OTHER

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Also known as: nerve block with 0.5% ropivacaine

Control Group

Eligibility Criteria

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

You may qualify if:

• \. Elective endoscopic binostril transnasal transsphenoidal resection
• \. Patients aged between 18 and 65.
• \. American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III

You may not qualify if:

• \. Emergency operation.
• \. Patients allergic to ropivacaine.
• \. Infection nearby the puncture point.
• \. Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse.
• \. Patient with renal insufficiency or hepatic failure.
• \. Patients who have undergone craniotomy in the recent 6 months.
• \. Pregnant or lactating women, being participating in other studies.
• \. Patients unable to cooperate.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pain

Interventions

Nerve Block; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients were randomly assigned to one of two groups by a single nurse, who was not involved in the anesthetic management of the patient, while using a computer-generated randomization sequence with random block sizes of two and four. The same nurse prepared syringes containing the nerve block solution. Syringes for the block group (Block group) were filled with 6 mL of 0.5% ropivacaine. The patient, surgeon,and investigator were all blinded to the study and the adequacy of the block.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. The patient's head was positioned on a central line in the supine position. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger . 2 mL of the study solution was slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the study solution was injected. Contralateral nerve block was performed in the same manner.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: September 26, 2022
• Study Start: September 1, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

CN (1)