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Superficial Cervical Plexus Block for Postoperative Analgesia

Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04036812
Enrollment
106
Registered
2019-07-30
Start date
2019-11-18
Completion date
2021-04-10
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plexus Block;Analgesia;Neurosurgery

Brief summary

The incidence of postoperative pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.

Interventions

superficial cervical plexus nerve block will be performed under the guidance of ultrasound

OTHERControl group

ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Elective suboccipital retrosigmoid approach approach craniotomy; 2. Age between 18 and 65 years; 3. American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion criteria

1. The patients or legal clients refuse to provide informed consent; 2. Local infection; 3. Preoperative impairment of consciousness and cognitive function; 4. Uncontrolled hypertension; 5. Inability to communicate; 6. Allergies to experimental drugs; 7. History of drug abuse; 8. History of chronic headache; 9. Aphasia and hearing impairment; 10. Patients undergoing second craniotomy; 11. Body mass index \< 18.5 kg/m2 or \> 35.0 kg/m2;

Design outcomes

Primary

MeasureTime frameDescription
the cumulative consumption of sufentanil by the PCA24 hours after surgerythe cumulative consumption of sufentanil by the PCA 24 hours after surgery

Secondary

MeasureTime frameDescription
Use of analgesics by the PCA after operationat 1, 2, 4, 48 hours after surgery.the cumulative consumption of sufentanil by PCA
Pain severity scoreat 1, 2, 4, 24, 48 hours after surgeryIt will be accessed using NRS
Anesthesia recovery quality score:at 1 hour after surgeryIt will be accessed at postoperative 1 and 2 hours using the Anesthesia Steward Emergence Scale. The Anesthesia Steward Emergence Scale(0-6) is divided into three parts: the degree of wakefulness - 2 points for complete recovery, 1 point for response to stimulation, 0 point for no response to stimulation; the degree of airway patency - 2 points for cough according to the doctor's order, 1 point for maintenance of airway patency without support, 0 point for support required for respiratory tract; 2 points for conscious activities of limbs with limb mobility, 1 point for unconscious activities of limbs, point for no activities of limbs.
Patient analgesic satisfactionat 24 hours after surgeryPatient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026