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Completed

NCT Number: NCT03411330

Safety and Efficacy of Addition of Hyaluronidase to Lidocaine and Bupivacaine in Scalp Nerves Block in Elective Craniotomy Operations, Comparative Study

Safety and efficacy of addition of hyaluronidase to lidocaine and bupivacaine in scalp nerves block in elective craniotomy operations,Comparative study

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

Patients undergoing craniotomy operations are susceptible to many injurious stimuli such as skin incision, insertion of cranial pins, dural incision, dural and skin closure. They cause different levels of nociception and these stimuli can result in sudden increases in blood pressure and heart rate due to triggering stress response.

Strategies to blunt these noxious stimuli and attenuate this stress response include administration of systemic opioids, deepening the level of anaesthesia. Scalp nerves block by local anaesthetics also can be used.

However, most systemically administered medications studied for post-craniotomy pain usually associated with side effects such as sedation, nausea, and vomiting and depressed ventilation such events are particularly important for post-craniotomy patients.

Using regional aesthetic techniques in addition to general anaesthesia have been conducted as multimodality managements for post-craniotomy pain and to decrease systemic administration of analgesics and hence decrease their systemic complications.

The stress response is the hormonal and metabolic changes that follow injury or trauma. This includes wide range of endocrinological and immunological effects. The stress response to surgery is characterized by increased secretion of pituitary hormones and activation of the sympathetic nervous system. Hypothalamic activation of the sympathetic autonomic nervous system results in increased secretion of catecholamines from the adrenal medulla and release of norepinephrine from presynaptic nerve terminals. IL-6 is produced in substantial quantities at the site of a surgical wound.IL-6 enters the circulation, and its concentration correlates with the severity of surgery and thus with the magnitude of the tissue injury. At 24 to 36 h after surgery, the levels of IL-6 in the plasma reach preoperative values, because its production is attenuated. Postoperative pain behaves like wound on plasma IL-6: intense postoperative pain correlates with the magnitude of tissue injury and subsides days after. Pain in the first 24 hours after brain surgery is a significant problem, with 60% to 80% of patients experiencing moderate to severe pain.

Blockade of scalp innervation which anesthetises both the superficial and deep layers of the scalp, was used as a means of decreasing hemodynamic reactions during and after craniotomy operations. Various protocols to control postoperative pain were suggested, including infiltration of the scalp with local anaesthetics. These include the use of 0.5% bupivacaine combined with additional lidocaine 2 %.

Hyaluronidase is a naturally produced enzyme, it's produced by various types of bacteria, and primary helps bacteria to dissolve hyaluronic acid that constitutes major component of the connective tissue substance thus helping spread of other bacterial products. On December 2005, the FDA approved a synthetic (recombinant or rDNA) human hyaluronidase. The addition of hyaluronidase to local anaesthetics has been shown to enhance safely and effectively the diffusion of the drug, thereby increasing the analgesic efficacy especially in the first minutes after injection

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA Ι and II.
  • Both males and females, age (18-60) years.
  • Supine position.
  • Glasco coma scale more than 12.
  • Elective craniotomy operations.

Exclusion criteria

  • ASA ΙII or IV
  • History of allergy to the study drugs.
  • Surgery to remove pituitary tumours or affecting pituitary hormones.
  • Glasco coma scale less than 12.
  • The need for postoperative ventilation.

Treatment and study plan

Hyaluronidase

Drug

Scalp nerves block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg in group A, Hyaluronidase will be added in group H in a dose of 1500 IU (The minimum and maximum effective doses of hyaluronidase are not known. The doses used range from0.75 IU/ml to 300 IU/ml

Other names: Hyaluronidase with lidocaine and bupivacaine

Lidocaine

Drug

lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%)

Other names: Lidocaine alone

Bupivacaine

Drug

bupivacaine (0.5%)

Other names: Bupivacaine alone

Primary outcomes

  1. Post-operative pain evaluation

    Time frame: up to 24 hours postoperatively

    Post-operative VAS for pain post-operative.

Secondary outcomes

  1. Haemodynamic Measures

    Time frame: Every 5 minutes during operation In first 24 hours postoperatively

    Effects on haemodynamics: Heart rate"beats per minute" intra and post-operative in both groups

  2. Interleukin 6 measurement

    Time frame: Interleukin 6 level will be measured before surgery (9:00 A.M),30 minutes after scalp nerves block, 60 minutes after skin incision and after 6 hours post-operative.

    Measurement of level of interleukin 6 as an indicator of inflammatory response and pain

  3. Intraoperative rescue dose of opioid

    Time frame: 6 hours postoperative then every 2 hours for 24 hours.

    Number of patients requiring intraoperative rescue doses of opioids

  4. Time of first analgesic request

    Time frame: Intraoperative

    First time to seek analgesia (time of first analgesic request)

  5. Haemodynamic effects

    Time frame: up to 24 hours postoperatively

    Effects on haemodynamics:, systolic, diastolic and mean arterial blood pressure" mm Hg".

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Badawy Mohammed Al-Kholy
  • Hatem Abdellatif Mohamed
  • Mohamed Mahmoud Mohamed
  • Mohamed, Ahmed A., M.D.
  • Tarek Ahmed Radwan

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.