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Completed

NCT Number: NCT05108337

Superficial Cervical Plexus Block for Postoperative Chronic Pain

The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. 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 incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.

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Key information

Conditions

Neurosurgery Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The patients or legal clients refuse to provide informed consent;
  • Local infection;
  • Preoperative impairment of consciousness and cognitive function;
  • Uncontrolled hypertension;
  • Inability to communicate;
  • Allergies to experimental drugs;
  • History of drug abuse;
  • History of chronic headache;
  • Aphasia and hearing impairment;
  • Patients undergoing second craniotomy;
  • Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;

Treatment and study plan

Superficial Cervical Plexus Block

Procedure

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 0.5% ropinacaine.

Control Group

Other

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.

Primary outcomes

  1. Chronic pain assessment

    Time frame: at 3 months after surgery.

    Follow-up visit will be conducted by telephone at 3 months after surgery.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2021
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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