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

Tongji Hospital

Status: Active, not recruiting

Conditions: Nerve Block; Pain

Treatments: Drug: nerve block with 0.5% ropivacaine; Other: without any nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT05555147

TJ2012S152

Details and patient eligibility

About

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.

Full description

Surgical stimulation is one of the important factors leading to hemodynamic fluctuation and affecting postoperative recovery quality. The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain because of there were numerous nerve endings at the surgical site which is originated from branches of the trigeminal nerve (including infraorbital and infratrochlear nerve). It's difficult to suppress intraoperative stimulation at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. It's reported that pterygomaxillary fossa block can inhibit hypertension caused by surgical procedures, however the block may cause complications because of its complicated operations. 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 reduce the pain in the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear. Therefore, the investigators propose the hypothesis that preoperative bilateral infraorbital and infratrochlear nerve block could effectively reduce the pain in patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary. The objective of this study is to observe the heart rate and blood pressure at a specific point in time during the operation and pain at 2, 8, 24, 48 hours postoperatively between adult patients receiving or not receiving bilateral infraorbital and infratrochlear nerve block.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Nerve Block Group

Experimental group

Description:

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.

Treatment:

Drug: nerve block with 0.5% ropivacaine

Control Group

Sham Comparator group

Description:

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Treatment:

Other: without any nerve block