Ignite Creation Date:
2024-05-06 @ 9:48 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03073889
Status:
UNKNOWN
Last Update Posted:
2017-03-08
First Post:
2017-01-06
Brief Title:
A Comparison Between Scalp Nerve Block and Scalp Infiltration
Sponsor:
Xi Yang
Organization:
Wuhan University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n15 Group I Scalp infiltration before incision n15 respectively with 075 of ropivacaine and Group C the control group n15 Opioids were used to control haemodynamic responsesAll 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 075 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 incisionafter 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
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 075 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 incisionafter 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 075 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 075 ropivacaine throughout the entire thickness of the scalpNeither scalp block nor local infiltration was performed in the control group group C
For group I patients neurosurgeons infiltrated the planned incision by a needle penetrated deeply to the skin with 075 ropivacaine throughout the entire thickness of the scalpNeither scalp block nor local infiltration was performed in the control group group C
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None