A Comparison Between Scalp Nerve Block and Scalp Infiltration

Aneurysm Clinical Trial

Official title:

A Comparison Between Scalp Nerve Block and Scalp Infiltration on the Circulatory and Stress Response for Aneurysm Clipping Using an Enhanced Recovery After Surgery Programme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03073889
• Other study ID #: 2016013
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: March 2, 2017
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: March 2017
• Source: Wuhan University
• Contact: Xi YANG
• Phone: 0086-18207195370
• Email: 18207195370[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Forty ASA I or II patients, scheduled for aneurysm clipping were enrolled in this prospective, randomized, controlled study. Those patients were randomly divided into 3 groups: Group B (Scalp nerve block before skin incision n=15), Group I (Scalp infiltration before incision n=15), respectively with 0.75% of ropivacaine, and Group C (the control group, n=15). Opioids were used to control haemodynamic responses.All patients received the same general anesthesia.

After intubation, in group B, scalp block was performed by blocking the nerves that innervate the scalp, including the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital and lesser occipital nerves, and skin along the incision was infiltrated with 0.75% ropivacaine (group I, n = 15), respectively. For group C, there is no treatment. All patients received the same general anesthesia. The depth of anaesthesia was adjusted to maintain a BIS of 40-60. Characteristics of patients were recorded. Heart rate (HR) and mean arterial pressure (MAP) were recorded preoperatively, after induction, before skin incision, the moment of incision, after skin incision. Plasma levels of IL-6, IL-10, CRP were measured before surgery, skin incision,after the surgery. Postoperative pain scores (VAS) for 2, 4, 8, 12, 24, 48 hours after recovery of consciousness were also recorded. Postoperative complications ( nausea, vomiting, infection, and other adverse events) were monitored after surgery.

Description:

For group B, the scalp block was performed bilaterally with 0.75% ropivacaine by the anesthesiologist. The supraorbital and supratrochlear nerves emerge from the orbit, and a needle was introduced above the eyebrow perpendicular to the skin with ropivacaine and was then gradually withdrawn with simultaneous injection of solutions throughout the entire. The zygomaticotemporal nerve emerge lateral to the orbit, equal to the position of pterion, this nerve was blocked with ropivacaine. The auriculotemporal nerve was blocked bilaterally anterior to the ear at the level of the tragus, the needle was introduced perpendicularly to the skin and infiltration was performed deep to the fascia and superficially as the needle was withdrawn. Care must be taken to avoid destroying superficial temporal artery. The greater, lesser, and third occipital nerves may be blocked using a needle, with infiltration along the superior nuchal line, approximately halfway between the occipital protuberance and the mastoid process.

For group I patients, neurosurgeons infiltrated the planned incision by a needle penetrated deeply to the skin with 0.75% ropivacaine throughout the entire thickness of the scalp.Neither scalp block nor local infiltration was performed in the control group (group C).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I or II

• Glasgow coma score (GSC) of 15

Exclusion criteria:

• ASA physical status of more than II

• A ruptured cerebral aneurysm and subarachnoid haemorrhage

• A history of allergy to opiates or any other drug used in the study

• Impaired renal, hepatic, or pulmonary function

• Allergic reaction to local anesthetics

Related Conditions & MeSH terms

• Aneurysm

Intervention

Procedure:
• Scalp Nerve Block
A scalp nerve block involves regional anesthesia to the nerves that innervate the scalp, including the supraorbital and supratrochlear nerves, branches of the ophthalmic branch of the trigeminal nerve; the zygomaticotemporal nerves, terminal branch of division two of the trigeminal nerve; the auriculotemporal nerves, terminal branch of the mandibular division of the trigeminal nerve; the greater and lesser occipital nerves. The scalp block is performed bilaterally with 10 solution of 0.75% ropivacaine.
• Scalp infiltration
Scalp infiltration before incision. Neurosurgeons infiltrate the planned incision by a 22-gauge needle penetrated deeply to the skin at a 45°angle with 10ml solution of 0.75% ropivacaine throughout the entire thickness of the scalp.

Drug:
• Ropivacaine

Locations

Country	Name	City	State
China	Zhongnan hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xi Yang

Country where clinical trial is conducted

China, 

References & Publications (4)

Leslie K, Troedel S. Does anaesthesia care affect the outcome following craniotomy? J Clin Neurosci. 2002 May;9(3):231-6. Review. — View Citation

Pakulski C, Nowicki R, Badowicz B, Bak P, Mikulski K, Wojnarska B. Effect of scalp infiltration with lidocaine on the circulatory response to craniotomy. Med Sci Monit. 2001 Jul-Aug;7(4):725-8. — View Citation

Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. — View Citation

Quiney N, Cooper R, Stoneham M, Walters F. Pain after craniotomy. A time for reappraisal? Br J Neurosurg. 1996 Jun;10(3):295-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of IL-10 in pg/ml	Change of plasma levels of IL-10	change from baseline IL-10 values at 24 hour hours after surgery
Secondary	Change of IL-6 in pg/ml	Change of plasma levels of IL-6	change for baseline IL-6 values at 24 hour hours after surgery
Secondary	Mean Arterial Pressure in mmHg		baseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling
Secondary	Heart Rate in bpm		baseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling
Secondary	Postoperative VAS scores		2, 4, 8, 12, 24, 48 hours after recovery of consciousness