A Comparison Between Scalp Nerve Block and Scalp Infiltration

Sponsor
Xi Yang (Other)
Overall Status
Unknown status
CT.gov ID
NCT03073889
Collaborator
(none)
45
1
3
10
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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orbit, and a needle was introduced above the eyebrow perpendicular to the skin with ropivacaine and was then gradually withdrawn with simultaneous injection of solutions throughout the entire.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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
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
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Block

Scalp nerve block with 10ml solution of 0.75% ropivacaine before skin incision, n=15

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.

Drug: Ropivacaine

Active Comparator: Infiltration

Scalp infiltration with 10ml solution of 0.75% ropivacaine before incision, n=15

Procedure: 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

No Intervention: Control

the control group has no treatment, n=15

Outcome Measures

Primary Outcome Measures

  1. Change of IL-10 in pg/ml [change from baseline IL-10 values at 24 hour hours after surgery]

    Change of plasma levels of IL-10

Secondary Outcome Measures

  1. Change of IL-6 in pg/ml [change for baseline IL-6 values at 24 hour hours after surgery]

    Change of plasma levels of IL-6

  2. 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]

  3. 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]

  4. Postoperative VAS scores [2, 4, 8, 12, 24, 48 hours after recovery of consciousness]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongnan hospital Wuhan Hubei China 430071

Sponsors and Collaborators

  • Xi Yang

Investigators

  • Study Chair: Mian PENG, Zhongnan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xi Yang, Principal Investigator, Wuhan University
ClinicalTrials.gov Identifier:
NCT03073889
Other Study ID Numbers:
  • 2016013
First Posted:
Mar 8, 2017
Last Update Posted:
Mar 8, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Xi Yang, Principal Investigator, Wuhan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2017