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A Comparison Between Scalp Nerve Block and Scalp Infiltration

Not Applicable
Conditions
Aneurysm
Interventions
Procedure: Scalp Nerve Block
Procedure: Scalp infiltration
Registration Number
NCT03073889
Lead Sponsor
Xi Yang
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orbit, and a needle was introduced above the eyebrow perpendicular to the skin with ropivacaine and was then gradually withdrawn with simultaneous injection of solutions throughout the entire.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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
45
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BlockScalp Nerve BlockScalp nerve block with 10ml solution of 0.75% ropivacaine before skin incision, n=15
BlockRopivacaineScalp nerve block with 10ml solution of 0.75% ropivacaine before skin incision, n=15
InfiltrationScalp infiltrationScalp infiltration with 10ml solution of 0.75% ropivacaine before incision, n=15
InfiltrationRopivacaineScalp infiltration with 10ml solution of 0.75% ropivacaine before incision, n=15
Primary Outcome Measures
NameTimeMethod
Change of IL-10 in pg/mlchange from baseline IL-10 values at 24 hour hours after surgery

Change of plasma levels of IL-10

Secondary Outcome Measures
NameTimeMethod
Postoperative VAS scores2, 4, 8, 12, 24, 48 hours after recovery of consciousness
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
Change of IL-6 in pg/mlchange for baseline IL-6 values at 24 hour hours after surgery

Change of plasma levels of IL-6

Trial Locations

Locations (1)

Zhongnan hospital

🇨🇳

Wuhan, Hubei, China

Zhongnan hospital
🇨🇳Wuhan, Hubei, China
Yuanzhen ZHANG
Contact
027-67812787
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