Clinical trial NCT04073069: Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
Official title: Pre-emptive Scalp Infiltration With Diprospan Plus Ropivacaine for 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
Ropivacaine
Pre-emptive Scalp Infiltration
Diprospan
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 96
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. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing 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. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. 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. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as diprospan as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity in knee osteoarthritis or in total knee arthroplasty. However, there has not been reported about local application of diprospan on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status of I , II or III;
* 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, diprospan 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 postoperatively
measure: Numerical rating scale (NRS)
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 (RSS)
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: The times of emergency reducing blood pressure after the operation
timeFrame: Within 48 hours after the operation
measure: Patient satisfactory scale (PSS)
timeFrame: t 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: The total consumption of opioids during the operation
timeFrame: During procedure
measure: The length of stay
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: Wound Healing Score
timeFrame: At 1 month 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: 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: 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: Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.
citation: Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.