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

Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200641
• Other study ID #: ACTRN12610000727044
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 10, 2010
• Last updated: October 10, 2012
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2012
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• 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).
• 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
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).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin university of medical science	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)		one minute after retrobulbar block placement	Yes
Primary	pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)		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)	Yes
Primary	pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)		postoperatively before discharging the patient from the recovery room	Yes
Primary	anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)		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)	Yes
Primary	anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)		one minute after retrobulbar block placement	Yes
Primary	anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)		postoperatively before discharging the patient from the recovery room	Yes
Secondary	mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement		before premedication	Yes
Secondary	mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement		ninety minutes after premedication, on arrival in the operating room	Yes
Secondary	mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement		one minute after retrobulbar block placement	Yes
Secondary	mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement		during the operation period(five minutes after beginning of surgery	Yes
Secondary	mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement		postoperatively before discharge the patient from the recovery room	Yes
Secondary	heart rate will be assessed by echocardiogram monitoring		before premedication	Yes
Secondary	heart rate will be assessed by echocardiogram monitoring		ninety minutes after premedication, on arrival in the operating room	Yes
Secondary	heart rate will be assessed by echocardiogram monitoring		one minute after retrobulbar block placement	Yes
Secondary	heart rate will be assessed by echocardiogram monitoring		during the operation period(five minutes after beginning of surgery	Yes
Secondary	heart rate will be assessed by echocardiogram monitoring		postoperatively before discharge the patient from the recovery room	Yes
Secondary	satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed		one minute after retrobulbar block placement	Yes
Secondary	satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed		at the end of surgery	Yes