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

Not Applicable

Active, not recruiting

• Conditions: Nerve Block; Pain
• Interventions: Other: without any nerve block; Drug: nerve block with 0.5% ropivacaine

• Registration Number: NCT05555147
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-01
• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	without any nerve block	Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.
Nerve Block Group	nerve block with 0.5% ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
heat rate (HR) before nerve block	before nerve block	heat rate (HR) before nerve block
MAP immediately after nasal mucosal dissection	immediately after nasal mucosal dissection	MAP immediately after nasal mucosal dissection
HR before septum resection	before septum resection	HR before septum resection
HR immediately after septum resection	immediately after septum resection	HR immediately after septum resection
MAP before sella bone resection	before sella bone resection	MAP before sella bone resection
HR before exploration of pituitary fossa	before exploration of pituitary fossa	HR 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 within 10 minutes after nerve block	within 10 minutes after nerve block	HR within 10 minutes after nerve block
HR before nasal mucosal dissection	before nasal mucosal dissection	HR before nasal mucosal dissection
HR immediately after nasal mucosal dissection	immediately after nasal mucosal dissection	HR immediately after nasal mucosal dissection
HR immediately after dural incision of sella	immediately after dural incision of sella	HR immediately after dural incision of sella
mean arterial pressure (MAP) before nerve block	before nerve block	mean arterial pressure (MAP) before nerve block
MAP before nasal mucosal dissection	before nasal mucosal dissection	MAP before nasal mucosal dissection
MAP immediately after septum resection	immediately after septum resection	MAP immediately after septum resection
HR before sella bone resection	before sella bone resection	HR before sella bone resection
MAP after sella bone resection	before sella bone resection	MAP after sella bone resection
MAP before dural incision of sella	before dural incision of sella	MAP before dural incision of sella
MAP before exploration of pituitary fossa	before exploration of pituitary fossa	MAP before exploration of pituitary fossa
MAP before septum resection	before septum resection	MAP before septum resection
HR immediately after sella bone resection	immediately after sella bone resection	HR immediately after sella bone resection
HR before dural incision of sella	before dural incision of sella	HR before dural incision of sella
MAP immediately after dural incision of sella	immediately after dural incision of sella	MAP immediately after dural incision of sella
MAP immediately after exploration of pituitary fossa	immediately after exploration of pituitary fossa	MAP immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa	immediately after exploration of pituitary fossa	HR immediately after exploration of pituitary fossa

Secondary Outcome Measures

Name	Time	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 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 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 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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China