Clinical trial NCT01200641: Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin
Official title: Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin ( A Randomized, Double-blind, Placebo-controlled Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anxiety
Pain
Keywords: melatonin
gabapentin
anxiety
pain
retrobulbar block
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Principle goals of sedation for eye surgery are to provide patient comfort and to allow the patient to stay calm during both retrobulbar injection and surgery. Insufficient sedation may not prevent the patient from moving during retrobulbar injection, whereas very deep sedation may result in respiratory complications during surgery .The investigators compared the effect of melatonin and gabapentin on the hemodynamic parameters, sedation ,anxiety, and pain and satisfaction profile in cataract surgery. After approval by the Hospital Evaluation Committee of Scientific Studies for ethical purpose and written informed consent, ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) 90 minutes before retrobulbar injection. . Hemodynamic parameters ,anxiety, sedation score , and pain during block and surgery, satisfaction of surgeon were assessed. . At the preoperative visit verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) and verbal anxiety score (VAS) ranging from 0 to 10 (0= completely calm, 10 = the worst possible anxiety) were explained to patients. Then a 20 gauge cannula was inserted into one of the two hands. Patients were monitored with electrocardiogram, noninvasive measurement of blood pressure, and pulse oximetry (SPO2). Retrobulbar nerve block was performed by the same ophthalmic surgeon who was unaware of group allocation with 1.5 ml of solution that prepared by nurse( lidocaine 2%and 0.5 ml bupivacaine) via the percutaneous route with a 25 G, 38 mm Atkinson needle (John Weiss \& Son Limited, Milton Keynes,England), at inferotemporal site. No patient received an additional facial nerve block. The investigators assessed the pain immediately after block and surgery. Anxiety score and pain score was recorded in each patient before premedication (T1), ninety minutes after premedication, on arrival in the operating room (T2), one minute after retrobulbar block placement (T3)during the operation period) (T4) and postoperatively before discharging the patient from the recovery room (T5) .At the end of surgery, the patients were asked about average level of their anxiety and pain during the operation period according to the VAS and VPS explained to them before premedication.'. The surgeon was also asked to verbally rate their level of satisfaction according to three degree scale as "very bad, , moderate, good after the operation. The sedation level of patients during performance of block was assessed as Sedation scores were obtained on a 3 point scale with 0 =movements of the head, arms and trunk ,1 =slightly movement of arms,2=slightly change in face,3=complete calm. If sedation was inadequate, fentanyl could be given 0.5microgram/kg as needed.


Eligibility criteria: Inclusion Criteria:

* patients who were aged 25 years or older, American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Patients with ASA status IV
* history of hepatic or renal disease, confusion, dementia
* communication difficulty resulting from deafness or language barrier
* chronic use of narcotics, barbiturates or psychotropic medications
* history of allergy or contraindications to any of the study drugs
* visual impairment of the non operative eye
* weight \< 40 kg or \> 100 kg

Primary outcomes:
measure: pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
timeFrame: one minute after retrobulbar block placement
measure: pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
timeFrame: At the end of surgery the patients were asked about average level of their pain during the operation period according to the VPS explained to them before premedication)
measure: pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
timeFrame: postoperatively before discharging the patient from the recovery room
measure: anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
timeFrame: At the end of surgery the patients were asked about average level of their pain during the operation period according to the VPS explained to them before premedication)
measure: anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
timeFrame: one minute after retrobulbar block placement
measure: anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
timeFrame: postoperatively before discharging the patient from the recovery room
Secondary outcomes:
measure: mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
timeFrame: before premedication
measure: mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
timeFrame: ninety minutes after premedication, on arrival in the operating room
measure: mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
timeFrame: one minute after retrobulbar block placement
measure: mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
timeFrame: during the operation period(five minutes after beginning of surgery
measure: mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
timeFrame: postoperatively before discharge the patient from the recovery room
measure: heart rate will be assessed by echocardiogram monitoring
timeFrame: before premedication
measure: heart rate will be assessed by echocardiogram monitoring
timeFrame: ninety minutes after premedication, on arrival in the operating room
measure: heart rate will be assessed by echocardiogram monitoring
timeFrame: one minute after retrobulbar block placement
measure: heart rate will be assessed by echocardiogram monitoring
timeFrame: during the operation period(five minutes after beginning of surgery
measure: heart rate will be assessed by echocardiogram monitoring
timeFrame: postoperatively before discharge the patient from the recovery room
measure: satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
timeFrame: one minute after retrobulbar block placement
measure: satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
timeFrame: at the end of surgery
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical science
Study officials:
References: