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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: The MP/RP group; Drug: The RP group

Study type: Interventional

Funder types: Other

Identifiers

NCT04078139

KY 2018-034-02-5

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

The MP/RP group

Experimental group

Description:

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

Treatment:

Drug: The MP/RP group

The RP group

Active Comparator group

Description:

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

Treatment:

Drug: The RP group