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NCT Number: NCT04036812

Superficial Cervical Plexus Block for Postoperative Analgesia

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.

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Key information

Conditions

Plexus Block;Analgesia;Neurosurgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

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

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. the cumulative consumption of sufentanil by the PCA

    Time frame: 24 hours after surgery

    the cumulative consumption of sufentanil by the PCA 24 hours after surgery

Secondary outcomes

  1. Use of analgesics by the PCA after operation

    Time frame: at 1, 2, 4, 48 hours after surgery.

    the cumulative consumption of sufentanil by PCA

  2. Pain severity score

    Time frame: at 1, 2, 4, 24, 48 hours after surgery

    It will be accessed using NRS

  3. Anesthesia recovery quality score：

    Time frame: at 1 hour after surgery

    It 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.

  4. Patient analgesic satisfaction

    Time frame: at 24 hours after surgery

    Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Feb 13, 2025

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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