Overview

This trial is active, not recruiting.

Condition posterior fossa tumors
Treatments bupivacaine, morphine patient controlled analgesia
Phase phase 2
Sponsor Istanbul University
Start date April 2014
End date December 2016
Trial size 45 participants
Trial identifier NCT02852382, Cerrahpasa Neuro

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.
bupivacaine Marcaine
In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
morphine patient controlled analgesia MORPHİNE PCA
End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
(Active Comparator)
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.
bupivacaine Marcaine
In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
morphine patient controlled analgesia MORPHİNE PCA
End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
(Placebo Comparator)
In this arm, neither scalp block, nor local infiltration will be performed.
morphine patient controlled analgesia MORPHİNE PCA
End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.

Primary Outcomes

Measure
Heart rate response to head pin replacement and skin incision
time frame: Intraoperative
Systolic arterial pressure response to head pin replacement and skin incision
time frame: Intraoperative
Diastolic arterial pressure response to head pin replacement and skin incision
time frame: Intraoperative
mean arterial pressure response to head pin replacement and skin incision
time frame: Intraoperative

Secondary Outcomes

Measure
postoperative pain
time frame: 30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS)
morphine consumption
time frame: 30. minute, 1.,2.,6.,12.,24. hours

Eligibility Criteria

Male or female participants from 16 years up to 70 years old.

Inclusion Criteria: - Posterior fossa surgery - Preoperative GlasGow Coma Score: 15/15 Exclusion Criteria: - Allergy to bupivacaine - Uncontrolled hypertension - Coagulopathy - Cerebrovascular disease - Earlier craniotomy

Additional Information

Official title The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Istanbul University.