Nerve Block, Pain
Conditions
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.
Interventions
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.
OTHERwithout any nerve block
Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HR immediately after exploration of pituitary fossa | immediately after exploration of pituitary fossa | HR immediately after exploration of pituitary fossa |
| MAP immediately after exploration of pituitary fossa | immediately after exploration of pituitary fossa | MAP immediately after exploration of pituitary fossa |
| HR before exploration of pituitary fossa | before exploration of pituitary fossa | HR before exploration of pituitary fossa |
| MAP before exploration of pituitary fossa | before exploration of pituitary fossa | MAP before exploration of pituitary fossa |
| MAP within 10 minutes after nerve block | within 10 minutes after nerve block | MAP within 10 minutes after nerve block |
| HR immediately after dural incision of sella | immediately after dural incision of sella | HR immediately after dural incision of sella |
| MAP immediately after dural incision of sella | immediately after dural incision of sella | MAP immediately after dural incision of sella |
| HR before dural incision of sella | before dural incision of sella | HR before dural incision of sella |
| MAP before dural incision of sella | before dural incision of sella | MAP before dural incision of sella |
| HR immediately after sella bone resection | immediately after sella bone resection | HR immediately after sella bone resection |
| MAP after sella bone resection | before sella bone resection | MAP after sella bone resection |
| HR before sella bone resection | before sella bone resection | HR before sella bone resection |
| MAP before sella bone resection | before sella bone resection | MAP before sella bone resection |
| HR immediately after septum resection | immediately after septum resection | HR immediately after septum resection |
| MAP immediately after septum resection | immediately after septum resection | MAP immediately after septum resection |
| HR before septum resection | before septum resection | HR before septum resection |
| MAP before septum resection | before septum resection | MAP before septum resection |
| HR immediately after nasal mucosal dissection | immediately after nasal mucosal dissection | HR immediately after nasal mucosal dissection |
| MAP immediately after nasal mucosal dissection | immediately after nasal mucosal dissection | MAP immediately after nasal mucosal dissection |
| HR before nasal mucosal dissection | before nasal mucosal dissection | HR before nasal mucosal dissection |
| MAP before nasal mucosal dissection | before nasal mucosal dissection | MAP before nasal mucosal dissection |
| HR within 10 minutes after nerve block | within 10 minutes after nerve block | HR within 10 minutes after nerve block |
| heat rate (HR) before nerve block | before nerve block | heat rate (HR) before nerve block |
| mean arterial pressure (MAP) before nerve block | before nerve block | mean arterial pressure (MAP) before nerve block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS 8 hours after surgery | 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. |
| quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery | 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. |
| 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 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. |
| numerical rating scale (NRS) score before patient leaves PACU | 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. |
| NRS 2 hours after surgery | 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. |
| NRS 24 hours after surgery | 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. |
| NRS 48 hours after surgery | 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. |
| quality of recovery Scale: QoR-15 3 days after surgery | 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. |
| quality of recovery Scale: QoR-15 7 days after surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative nausea and vomiting (PONV) within 24 hours | within 24h after surgery | 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 |
| incidence of local anesthetic toxicity in both two groups within 24 hours | within 24 hours after surgery | 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 |
| incidence of infection at the block point in both two groups within 24 hours | within 24 hours after surgery | 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 |
| incidence of hematoma at the block point in both two groups within 24 hours | within 24 hours after surgery | 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 |
| the dosage of remedial antiemetics within 48 hours | within 48 hours after surgery | the dosage of remedial antiemetics within 48 hours after surgery |
| the time of initial administration of remedial antiemetics within 48 hours | within 48 hours after surgery | the time of initial administration of remedial antiemetics within 48 hours after surgery |
| the dosage of remedial esmolol | during surgery | the dosage of remedial esmolol during surgery |
| the dosage of remedial perdipine | during surgery | the dosage of remedial perdipine during surgery |
| the dosage of remedial painkillers (remifentanil) | during surgery | the dosage of remedial painkillers (remifentanil) during surgery |
| maintenance infusion rate of remifentanil | during surgery | infusion rate of remifentanil for maintaining effective analgesic effect during surgery |
| bleeding volume | during surgery | bleeding volume during surgery |
| urine volume | during surgery | urine volume during surgery |
| anesthetic dosage | during surgery | use dosage of anesthetic drug during operation |
| PACU staying time | from the time of patient coming in PACU until the time of patient coming out PACU | time from the time of patient coming in PACU until the time of patient coming out PACU |
| 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 |
| anesthesia time | from the time of anesthesia beginning until end time of anesthesia | from the time of anesthesia beginning until end time of anesthesia |
| operation time | from the time of surgery beginning until end time of surgery | from the time of surgery beginning until end time of surgery |
| Ramsay sedation scale (RSS) 48 hours after surgery | 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). |
| Ramsay sedation scale (RSS) 24 hours after surgery | 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). |
| Ramsay sedation scale (RSS) 8 hours after surgery | 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). |
| Ramsay sedation scale (RSS) 2 hours after surgery | 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). |
| Ramsay sedation scale (RSS) before patient leaves PACU | 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). |
| Ramsay sedation scale (RSS) when patient enters PACU (immediately after surgery) | 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). |
| incidence of postoperative nausea and vomiting (PONV) within 48 hours | within 48 hours after surgery | 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 |
Countries
China
Outcome results
None listed