Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 65 years.

Both sexes.

American Society of Anesthesiologists (ASA) physical status I or II.

Undergoing supratentorial elective planned craniotomies.

Disqualifiers

Patients refusal.

History of known allergy to the used local anesthetic or dexmedetomidine.

Bleeding disorders.

Evidence of local infection at the site of injection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scalp block

    Other intervention

    Patients will receive a scalp block with bupivacaine alone.

  • Scalp block + Dexmedetomidine

    Other intervention

    Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group SBActive comparator 1 intervention
Group B: Group SDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative postoperative morphine consumption

If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg

Time frame
24 hours postoperatively

Secondary outcomes

1

Mean arterial pressure

Mean arterial pressure will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and postoperatively at 2, 4, 6,12, and 24 hours postoperatively.

Time frame
24 hours postoperatively
2

Heart rate

Heart rate will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and 2, 4, 6, 12, and 24 hours postoperatively.

Time frame
24 hours postoperatively
3

Degree of pain

Pain intensity will be evaluated on a 0-10 visual analog scale (VAS). The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The VAS score will be recorded at baseline (after admission to PACU), then after 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.

Time frame
24 hours postoperatively
4

Time for 1st rescue analgesia

Time for 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

Time frame
24 hours postoperatively

Other outcomes

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