Clinical trial NCT04034836: Parecoxib as an Adjuvant to Scalp Nerve Blocks for Relief of Post-craniotomy Pain
Official title: Parecoxib as an Adjuvant to Scalp Nerve Blocks for Relief of Post-craniotomy Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Neurosurgery
Keywords: Pain, Postoperative
Parecoxib
Ropivacaine
Scalp nerve blocks
Craniotomy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain is common for the first 2 days after major craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality.Pain after craniotomy derives from the scalp and pericranial muscles.Scalp block with local anesthesia seems to provide effective and safe anesthetic management.Scalp block can be performed by directly blocking the six different nerves that provide the sensory innervation of the scalp in neurological surgery.Even if adrenaline as an additive agent, scalp block using 0.5% or 0.75% bupivacaine with adrenaline could only improve postoperative analgesic for up to six hours after craniotomy.However, pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp nerve blocks does not seem to meet the requirements of craniotomy. Therefore, how to improve the quality and duration of scalp nerve blocks with local anesthetics is of great significance.Parecoxib is a NSAIDs that specifically inhibits the enzyme COX-2.Liu et al firstly applied parecoxib as an adjuvant to local anesthetics on peripheral nerve blocks and reported 20 mg parecoxib added to ropivacaine injected locally on the brachial plexus nerve prolonged the motor and sensory block times of the nerve blockade and ameliorated postoperative pain intensity for patients receiving forearm orthopaedic surgery. However, there has not been reported about local application of parecoxib on scalp nerve blocks. The investigators postulate that parecoxib may be also ideal for scalp nerve blocks for relief of post-craniotomy pain, and further research is needed.

The APONIA trial aims to establish whether scalp blocks with a mixture of ropivacaine plus parecoxib is able to relieve patients' postoperative pain compared with local anesthetics alone, thereby potentially changing medical practice.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 64 years
* American Society of Anesthesiologists (ASA) physical status of I, II and III
* Preoperative Glasgow Coma Scale (GCS) score of 15/15
* Scheduled for elective craniotomy under general anesthesia

Exclusion Criteria:

* Patients with chronic headache or chronic pain syndrome for any reason
* Patients with psychiatric disorders, uncontrolled epilepsy, coagulopathy, infection around puncture point
* Inability to understand and incapacity to use the pain scales before surgery
* Pregnancy or at breastfeeding;
* Participation in another intervention trial that interferes with the intervention or outcome of this trial
* History of allergies to any of the study drugs
* Refusal to participate or unable to acquire informed consent provided by the patients and/or legal guardian
* Having their first craniotomy surgery with an occipital bone defect
* Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, use of any painkiller within 24 hours before surgery
* Extreme body mass index (BMI) (\< 15 or \> 35);

Primary outcomes:
measure: The time to the first rescue analgesic
timeFrame: Within 48 hours after the operation
Secondary outcomes:
measure: Numerical rating scale of pain
timeFrame: At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
measure: Glasgow Coma Scale (GCS) score
timeFrame: At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
measure: The doses of extra sufentanil boluses
timeFrame: During the surgery
measure: Number of participates using extra sufentanil boluses
timeFrame: During the surgery
measure: Number of participates with postoperative nausea and vomiting (PONV)
timeFrame: Within 48 hours postoperatively
measure: Number of participates with bradycardia
timeFrame: Within 48 hours postoperatively
measure: Number of participates with hypotension
timeFrame: Within 48 hours postoperatively
measure: The time during PACU
timeFrame: Approximately 2 hours after the surgery
measure: Length of stay (LOS)
timeFrame: Approximately 2 weeks after the surgery
measure: Adverse Events
timeFrame: Approximately 2 weeks after the surgery
measure: Serious adverse events (SAEs)
timeFrame: Approximately 2 weeks after the surgery
measure: patient satisfaction score (PSS)
timeFrame: At 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
citation: Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
citation: Flexman AM, Ng JL, Gelb AW. Acute and chronic pain following craniotomy. Curr Opin Anaesthesiol. 2010 Oct;23(5):551-7. doi: 10.1097/ACO.0b013e32833e15b9.
citation: Dunn LK, Naik BI, Nemergut EC, Durieux ME. Post-Craniotomy Pain Management: Beyond Opioids. Curr Neurol Neurosci Rep. 2016 Oct;16(10):93. doi: 10.1007/s11910-016-0693-y.
citation: Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149.
citation: Lee EJ, Lee MY, Shyr MH, Cheng JT, Toung TJ, Mirski MA, Chen TY. Adjuvant bupivacaine scalp block facilitates stabilization of hemodynamics in patients undergoing craniotomy with general anesthesia: a preliminary report. J Clin Anesth. 2006 Nov;18(7):490-4. doi: 10.1016/j.jclinane.2006.02.014.
citation: Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048.
citation: Bala I, Gupta B, Bhardwaj N, Ghai B, Khosla VK. Effect of scalp block on postoperative pain relief in craniotomy patients. Anaesth Intensive Care. 2006 Apr;34(2):224-7. doi: 10.1177/0310057X0603400203.
citation: Romsing J, Moiniche S. A systematic review of COX-2 inhibitors compared with traditional NSAIDs, or different COX-2 inhibitors for post-operative pain. Acta Anaesthesiol Scand. 2004 May;48(5):525-46. doi: 10.1111/j.0001-5172.2004.00379.x.
citation: Romsing J, Moiniche S, Ostergaard D, Dahl JB. Local infiltration with NSAIDs for postoperative analgesia: evidence for a peripheral analgesic action. Acta Anaesthesiol Scand. 2000 Jul;44(6):672-83. doi: 10.1034/j.1399-6576.2000.440607.x.
citation: Koppert W, Wehrfritz A, Korber N, Sittl R, Albrecht S, Schuttler J, Schmelz M. The cyclooxygenase isozyme inhibitors parecoxib and paracetamol reduce central hyperalgesia in humans. Pain. 2004 Mar;108(1-2):148-53. doi: 10.1016/j.pain.2003.12.017.
citation: Williams DL, Pemberton E, Leslie K. Effect of intravenous parecoxib on post-craniotomy pain. Br J Anaesth. 2011 Sep;107(3):398-403. doi: 10.1093/bja/aer223.
citation: Liu X, Zhao X, Lou J, Wang Y, Shen X. Parecoxib added to ropivacaine prolongs duration of axillary brachial plexus blockade and relieves postoperative pain. Clin Orthop Relat Res. 2013 Feb;471(2):562-8. doi: 10.1007/s11999-012-2691-y. Epub 2012 Nov 21.
citation: Krauss P, Marahori NA, Oertel MF, Barth F, Stieglitz LH. Better Hemodynamics and Less Antihypertensive Medication: Comparison of Scalp Block and Local Infiltration Anesthesia for Skull-Pin Placement in Awake Deep Brain Stimulation Surgery. World Neurosurg. 2018 Dec;120:e991-e999. doi: 10.1016/j.wneu.2018.08.210. Epub 2018 Sep 7.