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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Sham Comparator | Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery) | numerical rating scale (NRS) score when patient enters PACU (immediately after surgery). The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | when patient enters PACU (immediately after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative nausea and vomiting (PONV) within 24 hours | within 24 hours after surgery, the investigators record the number of patients who suffer from PONV, and then calculate the incidence as: the number of patient suffering from PONV/the total number in corresponding group | within 24h after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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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.
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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.
|
| without any nerve block | Other | Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block. |
|
|
| 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 |
| numerical rating scale (NRS) score before patient leaves PACU | numerical rating scale (NRS) score before patient leaves PACU. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | before patient leaves PACU |
| NRS 2 hours after surgery | NRS 2 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 2 hours after surgery |
| NRS 8 hours after surgery | NRS 8 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 8 hours after surgery |
| NRS 24 hours after surgery | NRS 24 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 24 hours after surgery |
| NRS 48 hours after surgery | NRS 48 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 48 hours after surgery |
| quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery | quality of recovery Scale (QoR-15): QoR-15 1 day after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality. | 1 day after surgery |
| quality of recovery Scale: QoR-15 3 days after surgery | quality of recovery Scale: QoR-15 3 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality. | 3 days after surgery |
| quality of recovery Scale: QoR-15 7 days after surgery | quality of recovery Scale: QoR-15 7 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality. | 7 days after surgery |
| incidence of postoperative nausea and vomiting (PONV) within 48 hours |
within 48 hours after surgery, the investigators record the number of patients who suffer from PONV, and then calculate the incidence as: the number of patient suffering from PONV/the total number in corresponding group |
| within 48 hours after surgery |
| Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery) | Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery). The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation). | when patient enters PACU (immediately after surgery) |
| Ramsay sedation scale (RSS) before patient leaves PACU | Ramsay sedation scale (RSS) before patient leaves PACU. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation). | before patient leaves PACU |
| Ramsay sedation scale (RSS) 2 hours after surgery | Ramsay sedation scale (RSS) 2 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation). | 2 hours after surgery |
| Ramsay sedation scale (RSS) 8 hours after surgery | Ramsay sedation scale (RSS) 8 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation). | 8 hours after surgery |
| Ramsay sedation scale (RSS) 24 hours after surgery | Ramsay sedation scale (RSS) 24 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation). | 24 hours after surgery |
| Ramsay sedation scale (RSS) 48 hours after surgery | Ramsay sedation scale (RSS) 48 hours after surgery. The participants subjectively determine the patient's sedation scores using a 1 to 6 RSS (1=fidgety, 2-4=sedation satisfaction, 5-6=excessive sedation). | 48 hours after surgery |
| operation time | from the time of surgery beginning until end time of surgery | from the time of surgery beginning until end time of surgery |
| anesthesia time | from the time of anesthesia beginning until end time of anesthesia | from the time of anesthesia beginning until end time of anesthesia |
| awakening time | from the time of anesthesia end until the time of patient awaken | from the time of anesthesia end until the time of patient awaken |
| PACU staying time | time from the time of patient coming in PACU until the time of patient coming out PACU | from the time of patient coming in PACU until the time of patient coming out PACU |
| anesthetic dosage | use dosage of anesthetic drug during operation | during surgery |
| urine volume | urine volume during surgery | during surgery |
| bleeding volume | bleeding volume during surgery | during surgery |
| maintenance infusion rate of remifentanil | infusion rate of remifentanil for maintaining effective analgesic effect during surgery | during surgery |
| the dosage of remedial painkillers (remifentanil) | the dosage of remedial painkillers (remifentanil) during surgery | during surgery |
| the dosage of remedial perdipine | the dosage of remedial perdipine during surgery | during surgery |
| the dosage of remedial esmolol | the dosage of remedial esmolol during surgery | during surgery |
| the time of initial administration of remedial antiemetics within 48 hours | the time of initial administration of remedial antiemetics within 48 hours after surgery | within 48 hours after surgery |
| the dosage of remedial antiemetics within 48 hours | the dosage of remedial antiemetics within 48 hours after surgery | within 48 hours after surgery |
| incidence of hematoma at the block point in both two groups within 24 hours | within 24 hours after operation, the investigators record the number of patients who suffer from hematoma at the block point, and then calculate the incidence as: the number of patient suffering from hematoma at the block point/the total number in corresponding group | within 24 hours after surgery |
| incidence of infection at the block point in both two groups within 24 hours | within 24 hours after operation, the investigators record the number of patients who suffer from infection at the block point, and then calculate the incidence as: the number of patient suffering from infection at the block point/the total number in corresponding group | within 24 hours after surgery |
| incidence of local anesthetic toxicity in both two groups within 24 hours | within 24 hours after operation, the investigators record the number of patients who suffer from local anesthetic toxicity, and then calculate the incidence as: the number of patient suffering from local anesthetic toxicity/the total number in corresponding group | within 24 hours after surgery |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |