The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery

Istanbul University

Status and phase: Completed; Phase 2

Conditions: Posterior Fossa Tumors

Treatments: Drug: Bupivacaine; Drug: morphine patient controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02852382

Cerrahpasa Neuro

Details and patient eligibility

About

This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery

Full description

In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.

Enrollment: 45 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Posterior fossa surgery
• Preoperative GlasGow Coma Score: 15/15

Exclusion criteria

• Allergy to bupivacaine
• Uncontrolled hypertension
• Coagulopathy
• Cerebrovascular disease
• Earlier craniotomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

45 participants in 3 patient groups, including a placebo group

scalp block

Active Comparator group

Description:

In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine.

Treatment:

Drug: morphine patient controlled analgesia

Drug: Bupivacaine

local infiltration

Active Comparator group

Description:

In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area.

Treatment:

Drug: morphine patient controlled analgesia

Drug: Bupivacaine

control

Placebo Comparator group

Description:

In this arm, neither scalp block, nor local infiltration will be performed.

Treatment:

Drug: morphine patient controlled analgesia