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

NCT04078139 | Unknown Phase 4 DMC

• 1 other identifier: KY 2018-034-02-5
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Pain, Postoperative

Keywords

Postoperative Pain;; Post-Craniotomy;; Methylprednisolone; Ropivacaine; Scalp Infiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• The number of participants who have no butorphanol consumption

  Within 48 hours after the operation

• The first time to press the patient-controlled analgesia button

  Within 48 hours after the operation

• The total times that participants press patient-controlled analgesia button

  Within 48 hours postoperatively

• Numerical rating scale (NRS)

  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

• Postoperative nausea and vomiting

  At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery

Study Arms (2)

The MP/RP group

EXPERIMENTAL

Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline;

Drug: The MP/RP group

The RP group

ACTIVE COMPARATOR

Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline;

Drug: The RP group

Interventions

The MP/RP group DRUG

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 MP/RP group

The RP group DRUG

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.

The RP group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (7)

• 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.

  PMID: 24535791 BACKGROUND

• 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. doi: 10.1097/01.brs.0000232801.19965.a0.

  PMID: 16946657 BACKGROUND

• 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.

  PMID: 20022457 BACKGROUND

• 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.

  PMID: 25903913 BACKGROUND

• 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.

  PMID: 27996204 BACKGROUND

• 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.

  PMID: 27604271 BACKGROUND

• 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.

  PMID: 19630495 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo, M.D.

CONTACT

+86 13611326978; 13611326978@163.com

Chunmei Zhao, M.D.

CONTACT

+86 15510286930; zhaochunmei1206@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 4, 2019
• Study Start: March 5, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)