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A Comparison Between Scalp Nerve Block and Scalp Infiltration

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073889
Enrollment
45
Registered
2017-03-08
Start date
2016-06-30
Completion date
2017-04-30
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm

Keywords

Aneurysm Clipping, Scalp nerve block, Scalp infiltration, Ropivacaine

Brief 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.

Detailed 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).

Interventions

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.

PROCEDUREScalp 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.

DRUGRopivacaine

Sponsors

Xi Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of IL-10 in pg/mlchange from baseline IL-10 values at 24 hour hours after surgeryChange of plasma levels of IL-10

Secondary

MeasureTime frameDescription
Change of IL-6 in pg/mlchange for baseline IL-6 values at 24 hour hours after surgeryChange of plasma levels of IL-6
Mean Arterial Pressure in mmHgbaseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling
Heart Rate in bpmbaseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling
Postoperative VAS scores2, 4, 8, 12, 24, 48 hours after recovery of consciousness

Countries

China

Contacts

Primary ContactXi YANG
18207195370@163.com0086-18207195370
Backup ContactRui DONG
1095161439@qq.com086-13026317016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026