Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy

Pain, Postoperative Clinical Trial

Official title:

Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078139
• Other study ID #: KY 2018-034-02-5
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 5, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Beijing Tiantan Hospital
• Contact: Fang Luo, M.D.
• Phone: +86 13611326978
• Email: 13611326978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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 methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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, methylprednisolone 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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• The MP/RP group
Miscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
• The RP group
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Review. — View Citation

Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. — View Citation

Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T. Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014;24(1):48-53. doi: 10.5137/1019-5149.JTN.8431-13.0. — View Citation

Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative butorphanol consumption within 48 hours postoperatively	All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.	Within 48 hours after the operation
Secondary	The number of participants who have no butorphanol consumption	The number of participants who have not pushed the button of patient-controlled analgesia pump.	Within 48 hours after the operation
Secondary	The first time to press the patient-controlled analgesia button	The first time that the participants press the patient-controlled analgesia button.	Within 48 hours after the operation
Secondary	The total times that participants press patient-controlled analgesia button	The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.	Within 48 hours postoperatively
Secondary	Numerical rating scale (NRS)	Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).	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
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Secondary	Ramsay Sedation Scale (RSS)	Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Secondary	Respiratory depression	Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.	Within 48 hours after the operation
Secondary	The times of emergency reducing blood pressure after the operation	The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.	Within 48 hours after the operation
Secondary	Patient satisfactory scale (PSS)	0 for unsatisfactory, and 10 for very satisfied	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
Secondary	The total consumption of opioids during the operation	The total consumption of opioids during the operation	During procedure
Secondary	The length of stay	The duration of hospitalization after the operation	Approximately 2 weeks after the surgery
Secondary	The World Health Organization Quality of Life (WHOQOL)-BREF	Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.	At 1 month, 3 months and 6 months after surgery
Secondary	Wound Healing Score	Skin Healing 1: fully healed; 2: =3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis =3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: =0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: =3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable	At 1 month after surgery