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A Comparison Between Scalp Nerve Block and Scalp Infiltration

NCT03073889 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-03-08

No results posted yet for this study

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.

Conditions

  • Aneurysm

Interventions

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.

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

Sponsors & Collaborators

  • Xi Yang

    lead OTHER

Principal Investigators

  • Mian PENG · Zhongnan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03073889 on ClinicalTrials.gov