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

NCT ID: NCT03411330

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-24
• Study Completion Date: 2018-04-24

Brief Summary

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

Detailed Description

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

Conditions

Addition of Hyalase to Local Anesthetic in Scalp Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group H (Hyaluronidase added to local anaesthetics)

group H scalp block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg , Hyaluronidase will be added in in a dose of 1500 IU . The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block and not just a ring block. At the end of the scalp block further local anesthetic can be infiltrated locally to the pin sites and 7 nernes supraorbital nerve, a branch of the trigeminal nerve,supratrochlear nerve, a branch of the trigeminal nerve.

zygomaticotemporal nerve,auriculotemporal nerve, lesser occipital nerve, greater occipital nerve and greater auricular nerve

Group Type: ACTIVE_COMPARATOR

Hyaluronidase

Intervention Type: 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

Lidocaine

Intervention Type: DRUG

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

Bupivacaine

Intervention Type: DRUG

bupivacaine (0.5%)

Group A (local anaesthetics alone)

Group A :scalp nerves block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum dose of 175 mg The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block, and not just a ring block. At the end of the scalp block; further local anesthetic can be infiltrated locally to the pin sites and 7 nernes Supraorbital nerve, a branch of the trigeminal nerve.

supratrochlear nerve, a branch of the trigeminal nerve. zygomaticotemporal nerve, auriculotemporal nerve, lesser occipital nerve, greater occipital nerve, greater auricular nerve

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

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

Bupivacaine

Intervention Type: DRUG

bupivacaine (0.5%)

Interventions

Hyaluronidase

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

Intervention Type: DRUG

Lidocaine

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

Intervention Type: DRUG

Bupivacaine

bupivacaine (0.5%)

Intervention Type: DRUG

Other Intervention Names

Hyaluronidase with lidocaine and bupivacaine; Lidocaine alone; Bupivacaine alone

Eligibility Criteria

Inclusion Criteria

1. ASA Ι and II.

2. Both males and females, age (18-60) years.

3. Supine position.

4. Glasco coma scale more than 12.

5. Elective craniotomy operations.

Exclusion Criteria

1. ASA ΙII or IV

2. History of allergy to the study drugs.

3. Surgery to remove pituitary tumours or affecting pituitary hormones.

4. Glasco coma scale less than 12.

5. The need for postoperative ventilation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mohamed, Ahmed A., M.D.

INDIV

Sponsor Role: collaborator

Tarek Ahmed Radwan

UNKNOWN

Sponsor Role: collaborator

Mohamed Mahmoud Mohamed

UNKNOWN

Sponsor Role: collaborator

Hatem Abdellatif Mohamed

UNKNOWN

Sponsor Role: collaborator

Badawy Mohammed Al-Kholy

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdalla

Assistant Professor of Anesthesia&I.C.U and Pain Clinic, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abdalla Mohamed

Cairo, , Egypt

Countries

Egypt

References

Mohamed AA, Radwan TA, Mohamed MM, Mohamed HA, Mohamed Elemady MF, Osman SH, Safan TF, Khair TM, Ali NA, Fahmy RS, Belita MI, Abdalla SR, Seleem AA, Atta EM, Zaid OI, Ragab AS, Salem AE, AlKholy BM. Safety and efficacy of addition of hyaluronidase to a mixture of lidocaine and bupivacaine in scalp nerves block in elective craniotomy operations; comparative study. BMC Anesthesiol. 2018 Sep 15;18(1):129. doi: 10.1186/s12871-018-0590-9.

Reference Type: DERIVED

PMID: 30219027 (View on PubMed)

Other Identifiers

N-58/2017

Identifier Type: -

Identifier Source: org_study_id