Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin | RxWiki

Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Anxiety Pain
Intervention	Drug: Melatonin Drug: Gabapentin Drug: placebo
Phase	Phase 1/Phase 2
Sponsor	Qazvin University Of Medical Sciences
Responsible Party	Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier	NCT01200641
First Received	September 10, 2010
Last Updated	October 10, 2012
Last verified	October 2012

Tracking Information[ + expand ][ + ]

First Received Date	September 10, 2010
Last Updated Date	October 10, 2012
Start Date	September 2010
Estimated Primary Completion Date	January 2011
Current Primary Outcome Measures	pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [Time Frame: one minute after retrobulbar block placement] [Designated as safety issue: Yes] pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [Time Frame: 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)] [Designated as safety issue: Yes] pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [Time Frame: postoperatively before discharging the patient from the recovery room] [Designated as safety issue: Yes] anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [Time Frame: 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)] [Designated as safety issue: Yes] anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [Time Frame: one minute after retrobulbar block placement] [Designated as safety issue: Yes] anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [Time Frame: postoperatively before discharging the patient from the recovery room] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: before premedication] [Designated as safety issue: Yes] mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: ninety minutes after premedication, on arrival in the operating room] [Designated as safety issue: Yes] mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: one minute after retrobulbar block placement] [Designated as safety issue: Yes] mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: during the operation period(five minutes after beginning of surgery] [Designated as safety issue: Yes] mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: postoperatively before discharge the patient from the recovery room] [Designated as safety issue: Yes] heart rate will be assessed by echocardiogram monitoring [Time Frame: before premedication] [Designated as safety issue: Yes] heart rate will be assessed by echocardiogram monitoring [Time Frame: ninety minutes after premedication, on arrival in the operating room] [Designated as safety issue: Yes] heart rate will be assessed by echocardiogram monitoring [Time Frame: one minute after retrobulbar block placement] [Designated as safety issue: Yes] heart rate will be assessed by echocardiogram monitoring [Time Frame: during the operation period(five minutes after beginning of surgery] [Designated as safety issue: Yes] heart rate will be assessed by echocardiogram monitoring [Time Frame: postoperatively before discharge the patient from the recovery room] [Designated as safety issue: Yes] satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [Time Frame: one minute after retrobulbar block placement] [Designated as safety issue: Yes] satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [Time Frame: at the end of surgery] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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)
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1/Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Condition	Anxiety Pain
Intervention	Drug: Melatonin 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) orally 90 minutes before retrobulbar injection( for all of three groups). Drug: Gabapentin 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) orally 90 minutes before retrobulbar injection( for all of three groups). Drug: placebo 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) orally 90 minutes before retrobulbar injection( for all of three groups).
Study Arm (s)	Active Comparator: melatonin 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) orally 90 minutes before retrobulbar injection( for all of three groups). Active Comparator: gabapentin 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) orally 90 minutes before retrobulbar injection( for all of three groups). Placebo Comparator: placebo 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) orally 90 minutes before retrobulbar injection( for all of three groups).

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	90
Estimated Completion Date	January 2011
Estimated Primary Completion Date	December 2010
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
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01200641
Other Study ID Numbers	ACTRN12610000727044
Has Data Monitoring Committee	Yes
Information Provided By	Qazvin University Of Medical Sciences
Study Sponsor	Qazvin University Of Medical Sciences
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	October 2012

Locations[ + expand ][ + ]