Clinical trial NCT03618264: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy
Official title: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Post-Craniotomy Headache
Keywords: Postoperative Pain
Post-Craniotomy Headache
Dexamethasone
Ropivacaine
Pre-emptive Scalp Infiltration
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 140
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: A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. As a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status of I or II;
* Participates required to fix their head in a head clamp intraoperatively;
* Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria:

* History of craniotomy;
* Expected delayed extubation or no plan to extubate;
* Participants who cannot use a patient-controlled analgesia (PCA) device;
* Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Allergy to opioids, dexamethasone or ropivacaine;
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
* Pregnant or at breastfeeding;
* Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
* Preoperative Glasgow Coma Scale\< 15;
* Suspicion of intracranial hypertension;
* Peri-incisional infection;
* Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Primary outcomes:
measure: Cumulative sufentanil consumption within 48 hours postoperatively
timeFrame: Within 48 hours after the operation
Secondary outcomes:
measure: The number of participants who have no sufentanil consumption
timeFrame: Within 48 hours after the operation
measure: The first time to press the patient-controlled analgesia button
timeFrame: Within 48 hours after the operation
measure: The total times that participants press patient-controlled analgesia button
timeFrame: Within 48 hours after the operation
measure: Numerical rating scale of pain
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
measure: Postoperative nausea and vomiting
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: Ramsay Sedation Scale
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: Respiratory depression
timeFrame: Within 48 hours after the operation
measure: Heart rate
timeFrame: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: Mean arterial pressure
timeFrame: Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: The times of emergency reducing blood pressure after the operation
timeFrame: Within 48 hours after the operation
measure: Patient satisfactory scale (PSS)
timeFrame: At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
measure: The total consumption of opioids during the operation
timeFrame: During procedure
measure: The total consumption of anaesthetic during the operation
timeFrame: During procedure
measure: The duration of hospitalization after the operation
timeFrame: Approximately 2 weeks after the operation
measure: The World Health Organization Quality of Life (WHOQOL)-BREF
timeFrame: At 1 month, 3 months and 6 months after surgery
measure: Incisional related adverse events Incisional related adverse events
timeFrame: Within 1 month after surgery
measure: Wound Healing Score
timeFrame: At 3 weeks and 6 weeks after surgery
measure: Patient and Observer Scar Assessment Scale
timeFrame: At 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rocha-Filho PA. Post-craniotomy headache: a clinical view with a focus on the persistent form. Headache. 2015 May;55(5):733-8. doi: 10.1111/head.12563. Epub 2015 Apr 22.
citation: Vallapu S, Panda NB, Samagh N, Bharti N. Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Postcraniotomy Pain: A Double-Blind Randomized Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):73-79. doi: 10.4103/jnrp.jnrp_310_17.
citation: Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
citation: Chowdhury T, Garg R, Sheshadri V, Venkatraghavan L, Bergese SD, Cappellani RB, Schaller B. Perioperative Factors Contributing the Post-Craniotomy Pain: A Synthesis of Concepts. Front Med (Lausanne). 2017 Mar 1;4:23. doi: 10.3389/fmed.2017.00023. eCollection 2017.
citation: Akcil EF, Dilmen OK, Vehid H, Ibisoglu LS, Tunali Y. Which one is more effective for analgesia in infratentorial craniotomy? The scalp block or local anesthetic infiltration. Clin Neurol Neurosurg. 2017 Mar;154:98-103. doi: 10.1016/j.clineuro.2017.01.018. Epub 2017 Jan 30.
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: Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.
citation: Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
citation: Misra S, Koshy T, Suneel PR. Oral clonidine attenuates the fall in mean arterial pressure due to scalp infiltration with epinephrine-lidocaine solution in patients undergoing craniotomy: a prospective, randomized, double-blind, and placebo controlled trial. J Neurosurg Anesthesiol. 2009 Oct;21(4):297-301. doi: 10.1097/ANA.0b013e3181ac7a31.
citation: Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.