Clinical trial NCT04036812: Superficial Cervical Plexus Block for Postoperative Analgesia
Official title: Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plexus Block;Analgesia;Neurosurgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: the cumulative consumption of sufentanil by the PCA
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Use of analgesics by the PCA after operation
timeFrame: at 1, 2, 4, 48 hours after surgery.
measure: Pain severity score
timeFrame: at 1, 2, 4, 24, 48 hours after surgery
measure: Anesthesia recovery quality score：
timeFrame: at 1 hour after surgery
measure: Patient analgesic satisfaction
timeFrame: at 24 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing TianTan Hospital
Study officials:
affiliation: Beijing Tian Tan Hospital, Capital Medical University
name: Yuming Peng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeng M, Li R, Xu X, Wang D, Dong J, Li S, Kass IS, Peng Y, Jia W. Ultrasound-guided superficial cervical plexus block reduces opioid consumption in patients undergoing craniotomy via suboccipital retrosigmoid approach: a randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 29:rapm-2022-103534. doi: 10.1136/rapm-2022-103534. Online ahead of print.
citation: Peng K, Zeng M, Dong J, Yan X, Wang D, Li S, Peng Y. Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 5;10(2):e034003. doi: 10.1136/bmjopen-2019-034003.