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

NCT03411330 | Completed Early Phase 1 DMC

• 1 other identifier: N-58/2017
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Addition of Hyalase to Local Anesthetic in Scalp Block

Outcome Measures

Primary Outcomes (1)

• Post-operative pain evaluation

  Post-operative VAS for pain post-operative.

  up to 24 hours postoperatively

Secondary Outcomes (5)

• Haemodynamic Measures

  Every 5 minutes during operation In first 24 hours postoperatively

• Interleukin 6 measurement

  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.

• Intraoperative rescue dose of opioid

  6 hours postoperative then every 2 hours for 24 hours.

• Time of first analgesic request

  Intraoperative

• Haemodynamic effects

  up to 24 hours postoperatively

Study Arms (2)

Group H (Hyaluronidase added to local anaesthetics)

ACTIVE COMPARATOR

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

Drug: Hyaluronidase; Drug: Lidocaine; Drug: Bupivacaine

Group A (local anaesthetics alone)

ACTIVE COMPARATOR

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

Drug: Lidocaine; Drug: Bupivacaine

Interventions

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

Also known as: Hyaluronidase with lidocaine and bupivacaine

Group H (Hyaluronidase added to local anaesthetics)

Lidocaine DRUG

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

Also known as: Lidocaine alone

Group A (local anaesthetics alone); Group H (Hyaluronidase added to local anaesthetics)

Bupivacaine DRUG

bupivacaine (0.5%)

Also known as: Bupivacaine alone

Group A (local anaesthetics alone); Group H (Hyaluronidase added to local anaesthetics)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Tarek Ahmed Radwan: collaborator
• Mohamed Mahmoud Mohamed: collaborator
• Hatem Abdellatif Mohamed: collaborator
• Badawy Mohammed Al-Kholy: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Related Publications (1)

• 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.

  PMID: 30219027 DERIVED

MeSH Terms

Interventions

Hyaluronoglucosaminidase; Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Prospective randomized double blinded clinical study on humans
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia&I.C.U and Pain Clinic, Cairo University

Model Details: The investigators hypothesize that, the addition of hyaluronidase may affect the quality of the block by enhancing the spread of the local anaesthetics through the facial planes and thus, reaching the target nerves more easily, rapid and effective that may provide better effective block in short duration and lasting for longer duration. This effect will be measured in terms of "stress response" and " analgesic quality" Total sample size of 64 patients randomly allocated into two equal groups. According to study "Hyaluronidase in sub-Tenon's anesthesia for phacoemulsification" that was done and published in International Journal of Ophthalmology (2012) to detect difference in post-operative pain between those patients receiving Lidocaine only versus Lidocaine and hyaluronidase, sample size of 29 patients per group is needed with confidence level 95% power of the study 80% \& type I error 0.05. Sample size calculation was done using Medcalc Software version 15.4.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 26, 2018
• Study Start: January 24, 2017
• Primary Completion: April 22, 2018
• Study Completion: April 24, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)