NCT03073889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

January 6, 2017

Last Update Submit

March 2, 2017

Conditions

Aneurysm

Keywords

Aneurysm ClippingScalp nerve blockScalp infiltrationRopivacaine

Outcome Measures

Primary Outcomes (1)

  • Change of IL-10 in pg/ml

    Change of plasma levels of IL-10

    change from baseline IL-10 values at 24 hour hours after surgery

Secondary Outcomes (4)

  • Change of IL-6 in pg/ml

    change for baseline IL-6 values at 24 hour hours after surgery

  • 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

  • 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

  • Postoperative VAS scores

    2, 4, 8, 12, 24, 48 hours after recovery of consciousness

Study Arms (3)

Block

EXPERIMENTAL

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

Procedure: Scalp Nerve BlockDrug: Ropivacaine

Infiltration

ACTIVE COMPARATOR

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

Procedure: Scalp infiltrationDrug: Ropivacaine

Control

NO INTERVENTION

the control group has no treatment, n=15

Interventions

Scalp Nerve BlockPROCEDURE

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.

Block
Scalp infiltrationPROCEDURE

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.

Infiltration
RopivacaineDRUG
BlockInfiltration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical status I or II
  • Glasgow coma score (GSC) of 15

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan hospital

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 12093125BACKGROUND

  • 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.

    PMID: 8799542BACKGROUND

  • 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.

    PMID: 11433201RESULT

  • 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.

    PMID: 8942596RESULT

  • 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.

    PMID: 31153358DERIVED

MeSH Terms

Conditions

Aneurysm

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mian PENG

    Zhongnan Hospital

    STUDY CHAIR

Central Study Contacts

Xi YANG

CONTACT

0086-1820719537018207195370@163.com

Rui DONG

CONTACT

086-130263170161095161439@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2017

First Posted

March 8, 2017

Study Start

June 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)