Clinical trial NCT05555147: The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Period of Hypophysectomy
Official title: The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Nerve Block
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean arterial pressure (MAP) before nerve block
timeFrame: before nerve block
measure: heat rate (HR) before nerve block
timeFrame: before nerve block
measure: MAP within 10 minutes after nerve block
timeFrame: within 10 minutes after nerve block
measure: HR within 10 minutes after nerve block
timeFrame: within 10 minutes after nerve block
measure: MAP before nasal mucosal dissection
timeFrame: before nasal mucosal dissection
measure: HR before nasal mucosal dissection
timeFrame: before nasal mucosal dissection
measure: MAP immediately after nasal mucosal dissection
timeFrame: immediately after nasal mucosal dissection
measure: HR immediately after nasal mucosal dissection
timeFrame: immediately after nasal mucosal dissection
measure: MAP before septum resection
timeFrame: before septum resection
measure: HR before septum resection
timeFrame: before septum resection
measure: MAP immediately after septum resection
timeFrame: immediately after septum resection
measure: HR immediately after septum resection
timeFrame: immediately after septum resection
measure: MAP before sella bone resection
timeFrame: before sella bone resection
measure: HR before sella bone resection
timeFrame: before sella bone resection
measure: MAP after sella bone resection
timeFrame: before sella bone resection
measure: HR immediately after sella bone resection
timeFrame: immediately after sella bone resection
measure: MAP before dural incision of sella
timeFrame: before dural incision of sella
measure: HR before dural incision of sella
timeFrame: before dural incision of sella
measure: MAP immediately after dural incision of sella
timeFrame: immediately after dural incision of sella
measure: HR immediately after dural incision of sella
timeFrame: immediately after dural incision of sella
measure: MAP before exploration of pituitary fossa
timeFrame: before exploration of pituitary fossa
measure: HR before exploration of pituitary fossa
timeFrame: before exploration of pituitary fossa
measure: MAP immediately after exploration of pituitary fossa
timeFrame: immediately after exploration of pituitary fossa
measure: HR immediately after exploration of pituitary fossa
timeFrame: immediately after exploration of pituitary fossa
Secondary outcomes:
measure: numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)
timeFrame: when patient enters PACU (immediately after surgery)
measure: numerical rating scale (NRS) score before patient leaves PACU
timeFrame: before patient leaves PACU
measure: NRS 2 hours after surgery
timeFrame: 2 hours after surgery
measure: NRS 8 hours after surgery
timeFrame: 8 hours after surgery
measure: NRS 24 hours after surgery
timeFrame: 24 hours after surgery
measure: NRS 48 hours after surgery
timeFrame: 48 hours after surgery
measure: quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery
timeFrame: 1 day after surgery
measure: quality of recovery Scale: QoR-15 3 days after surgery
timeFrame: 3 days after surgery
measure: quality of recovery Scale: QoR-15 7 days after surgery
timeFrame: 7 days after surgery
Other outcomes:
measure: incidence of postoperative nausea and vomiting (PONV) within 24 hours
timeFrame: within 24h after surgery
measure: incidence of postoperative nausea and vomiting (PONV) within 48 hours
timeFrame: within 48 hours after surgery
measure: Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery)
timeFrame: when patient enters PACU (immediately after surgery)
measure: Ramsay sedation scale (RSS) before patient leaves PACU
timeFrame: before patient leaves PACU
measure: Ramsay sedation scale (RSS) 2 hours after surgery
timeFrame: 2 hours after surgery
measure: Ramsay sedation scale (RSS) 8 hours after surgery
timeFrame: 8 hours after surgery
measure: Ramsay sedation scale (RSS) 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Ramsay sedation scale (RSS) 48 hours after surgery
timeFrame: 48 hours after surgery
measure: operation time
timeFrame: from the time of surgery beginning until end time of surgery
measure: anesthesia time
timeFrame: from the time of anesthesia beginning until end time of anesthesia
measure: awakening time
timeFrame: from the time of anesthesia end until the time of patient awaken
measure: PACU staying time
timeFrame: from the time of patient coming in PACU until the time of patient coming out PACU
measure: anesthetic dosage
timeFrame: during surgery
measure: urine volume
timeFrame: during surgery
measure: bleeding volume
timeFrame: during surgery
measure: maintenance infusion rate of remifentanil
timeFrame: during surgery
measure: the dosage of remedial painkillers (remifentanil)
timeFrame: during surgery
measure: the dosage of remedial perdipine
timeFrame: during surgery
measure: the dosage of remedial esmolol
timeFrame: during surgery
measure: the time of initial administration of remedial antiemetics within 48 hours
timeFrame: within 48 hours after surgery
measure: the dosage of remedial antiemetics within 48 hours
timeFrame: within 48 hours after surgery
measure: incidence of hematoma at the block point in both two groups within 24 hours
timeFrame: within 24 hours after surgery
measure: incidence of infection at the block point in both two groups within 24 hours
timeFrame: within 24 hours after surgery
measure: incidence of local anesthetic toxicity in both two groups within 24 hours
timeFrame: within 24 hours after surgery
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: