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A Comparison Between Scalp Nerve Block and Scalp Infiltration

Primary Purpose

Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Scalp Nerve Block
Scalp infiltration
Ropivacaine
Sponsored by
Xi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aneurysm focused on measuring Aneurysm Clipping, Scalp nerve block, Scalp infiltration, Ropivacaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zhongnan hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Block

Infiltration

Control

Arm Description

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

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

the control group has no treatment, n=15

Outcomes

Primary Outcome Measures

Change of IL-10 in pg/ml
Change of plasma levels of IL-10

Secondary Outcome Measures

Change of IL-6 in pg/ml
Change of plasma levels of IL-6
Mean Arterial Pressure in mmHg
Heart Rate in bpm
Postoperative VAS scores

Full Information

First Posted
January 6, 2017
Last Updated
March 2, 2017
Sponsor
Xi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT03073889
Brief Title
A Comparison Between Scalp Nerve Block and Scalp Infiltration
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xi Yang

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm
Keywords
Aneurysm Clipping, Scalp nerve block, Scalp infiltration, Ropivacaine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Block
Arm Type
Experimental
Arm Description
Scalp nerve block with 10ml solution of 0.75% ropivacaine before skin incision, n=15
Arm Title
Infiltration
Arm Type
Active Comparator
Arm Description
Scalp infiltration with 10ml solution of 0.75% ropivacaine before incision, n=15
Arm Title
Control
Arm Type
No Intervention
Arm Description
the control group has no treatment, n=15
Intervention Type
Procedure
Intervention Name(s)
Scalp Nerve Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Scalp infiltration
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
Change of IL-10 in pg/ml
Description
Change of plasma levels of IL-10
Time Frame
change from baseline IL-10 values at 24 hour hours after surgery
Secondary Outcome Measure Information:
Title
Change of IL-6 in pg/ml
Description
Change of plasma levels of IL-6
Time Frame
change for baseline IL-6 values at 24 hour hours after surgery
Title
Mean Arterial Pressure in mmHg
Time Frame
baseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling
Title
Heart Rate in bpm
Time Frame
baseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling
Title
Postoperative VAS scores
Time Frame
2, 4, 8, 12, 24, 48 hours after recovery of consciousness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xi YANG
Phone
0086-18207195370
Email
18207195370@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rui DONG
Phone
086-13026317016
Email
1095161439@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mian PENG
Organizational Affiliation
Zhongnan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongnan hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanzhen ZHANG
Phone
027-67812787

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12093125
Citation
Leslie K, Troedel S. Does anaesthesia care affect the outcome following craniotomy? J Clin Neurosci. 2002 May;9(3):231-6. doi: 10.1054/jocn.2001.0934. No abstract available.
Results Reference
background
PubMed Identifier
8799542
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. doi: 10.1080/02688699650040179.
Results Reference
background
PubMed Identifier
11433201
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.
Results Reference
result
PubMed Identifier
8942596
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. doi: 10.1097/00000539-199612000-00022.
Results Reference
result
PubMed Identifier
31153358
Citation
Yang X, Ma J, Li K, Chen L, Dong R, Lu Y, Zhang Z, Peng M. A comparison of effects of scalp nerve block and local anesthetic infiltration on inflammatory response, hemodynamic response, and postoperative pain in patients undergoing craniotomy for cerebral aneurysms: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):91. doi: 10.1186/s12871-019-0760-4.
Results Reference
derived

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A Comparison Between Scalp Nerve Block and Scalp Infiltration

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