Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture
Condition: Nalbuphine,Fentanyl and Local Anesthetic Mixture
Study type: Interventional
Phase: Phase 4

Summary: 
      Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal
      anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration
      of postoperative analgesia. The aim of this study is evaluation of the effect of 4 mg
      Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block
      undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl
      20 μg to LAM and LAM alone
    

Detailed description: 
      120 patients (40 in each group) scheduled for elective posterior chamber surgery using
      peribulbar block. Patients of Group N received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase
      (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group F
      received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20
      μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml
      hyaluronidase (75 IU) and1 ml saline (total 8 ml).

      Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe
      akinesia, total 15-min akinesia score and duration of block.

      Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure
      and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was
      hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of >5.

      Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood
      pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops
      0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam
      (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal
      oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for
      each group was injected in the medial canthus (the tunnel between the caruncle and the medial
      canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle
      and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction
      of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5
      ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle
      directed downward and medially below the globe. Light orbital compression applied for 1
      minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and
      chemosis.

      All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP,
      DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.
    

Intervention name(s): Nalbuphine Group; Fentanyl Group; Control Group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline; All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline; All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group C (Control group): included patients assigned to receive 1 ml normal saline.
Other intervention name(s): Group N; Group F; Group C
Intervention MeSH terms: Fentanyl; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care