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Clinical Trials/NCT05555147
NCT05555147
Active, not recruiting
Not Applicable

The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study

Tongji Hospital1 site in 1 country120 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
nerve block with 0.5% ropivacaine
Conditions
Pain
Sponsor
Tongji Hospital
Enrollment
120
Locations
1
Primary Endpoint
HR before septum resection
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
September 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Feng Gao

Professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Elective endoscopic binostril transnasal transsphenoidal resection
  • Patients aged between 18 and
  • American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III

Exclusion Criteria

  • Emergency operation.
  • Patients allergic to ropivacaine.
  • Infection nearby the puncture point.
  • Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse.
  • Patient with renal insufficiency or hepatic failure.
  • Patients who have undergone craniotomy in the recent 6 months.
  • Pregnant or lactating women, being participating in other studies.
  • Patients unable to cooperate.

Arms & Interventions

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.

Intervention: nerve block with 0.5% ropivacaine

Control Group

Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.

Intervention: without any nerve block

Outcomes

Primary Outcomes

HR before septum resection

Time Frame: before septum resection

HR before septum resection

heat rate (HR) before nerve block

Time Frame: before nerve block

heat rate (HR) before nerve block

MAP immediately after nasal mucosal dissection

Time Frame: immediately after nasal mucosal dissection

MAP immediately after nasal mucosal dissection

HR immediately after septum resection

Time Frame: immediately after septum resection

HR immediately after septum resection

MAP before sella bone resection

Time Frame: before sella bone resection

MAP before sella bone resection

HR before exploration of pituitary fossa

Time Frame: before exploration of pituitary fossa

HR before exploration of pituitary fossa

MAP within 10 minutes after nerve block

Time Frame: within 10 minutes after nerve block

MAP within 10 minutes after nerve block

HR within 10 minutes after nerve block

Time Frame: within 10 minutes after nerve block

HR within 10 minutes after nerve block

HR before nasal mucosal dissection

Time Frame: before nasal mucosal dissection

HR before nasal mucosal dissection

HR immediately after nasal mucosal dissection

Time Frame: immediately after nasal mucosal dissection

HR immediately after nasal mucosal dissection

HR immediately after dural incision of sella

Time Frame: immediately after dural incision of sella

HR immediately after dural incision of sella

mean arterial pressure (MAP) before nerve block

Time Frame: before nerve block

mean arterial pressure (MAP) before nerve block

MAP before nasal mucosal dissection

Time Frame: before nasal mucosal dissection

MAP before nasal mucosal dissection

MAP immediately after septum resection

Time Frame: immediately after septum resection

MAP immediately after septum resection

HR before sella bone resection

Time Frame: before sella bone resection

HR before sella bone resection

MAP after sella bone resection

Time Frame: before sella bone resection

MAP after sella bone resection

MAP before dural incision of sella

Time Frame: before dural incision of sella

MAP before dural incision of sella

MAP before exploration of pituitary fossa

Time Frame: before exploration of pituitary fossa

MAP before exploration of pituitary fossa

MAP before septum resection

Time Frame: before septum resection

MAP before septum resection

HR immediately after sella bone resection

Time Frame: immediately after sella bone resection

HR immediately after sella bone resection

HR before dural incision of sella

Time Frame: before dural incision of sella

HR before dural incision of sella

MAP immediately after dural incision of sella

Time Frame: immediately after dural incision of sella

MAP immediately after dural incision of sella

MAP immediately after exploration of pituitary fossa

Time Frame: immediately after exploration of pituitary fossa

MAP immediately after exploration of pituitary fossa

HR immediately after exploration of pituitary fossa

Time Frame: immediately after exploration of pituitary fossa

HR immediately after exploration of pituitary fossa

Secondary Outcomes

  • numerical rating scale (NRS) score before patient leaves PACU(before patient leaves PACU)
  • NRS 24 hours after surgery(24 hours after surgery)
  • NRS 2 hours after surgery(2 hours after surgery)
  • NRS 8 hours after surgery(8 hours after surgery)
  • quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery(1 day after surgery)
  • quality of recovery Scale: QoR-15 3 days after surgery(3 days after surgery)
  • NRS 48 hours after surgery(48 hours after surgery)
  • numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)(when patient enters PACU (immediately after surgery))
  • quality of recovery Scale: QoR-15 7 days after surgery(7 days after surgery)

Study Sites (1)

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