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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Nerve Block Group

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.

Group Type EXPERIMENTAL

nerve block with 0.5% ropivacaine

Intervention Type 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.

Control Group

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Group Type SHAM_COMPARATOR

without any nerve block

Intervention Type OTHER

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Interventions

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nerve block with 0.5% ropivacaine

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.

Intervention Type DRUG

without any nerve block

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Intervention Type OTHER

Other Intervention Names

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nerve block with 0.5% ropivacaine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No