A clinical study to evaluate effectiveness of drug tramadol for pain free period after gynecological surgeries

Not yet recruiting

Conditions: Noninflammatory disorders of female genital tract,

Registration Number: CTRI/2020/08/027221

Lead Sponsor: Shree krishna hospital

Brief Summary: Intrathecal opioid administration has been demonstrated to provide effective postoperative analgesia after a variety of surgical procedures, albeit at the cost of an increased risk for respiratory depression. Tramadol, in contrast, is a centrally acting analgesic that has minimal respiratory depressant effects, by virtue of its 6000-fold decreased affinity for mu receptors compared with morphine. It also inhibits serotonin and norepinephrine reuptake in the spinal cord and has no reported neural toxicity. Accordingly, tramadol has the potential to provide effective postoperative analgesia with no risk of respiratory depression after central neuraxial administration. Although epidural tramadol has been demonstrated to provide adequate postoperative analgesia in patients undergoingmajor abdominal surgery and Caesarean section, its efficacy after intrathecal administration has not yet been studied well. Now a days various adjuvants are used in spinal anesthesia like dexmedetomadin and fentanyl to prolong the duration of sensory blockade and post op analgesia, but tramadol is far more cost effective than dexmedetomedin and other adjuvants. So, The study is undertaken to evaluate the duration of analgesia and/or pain free period produced by intra thecal tramadol added to bupivacaine heavy in pts undergoing any infra umbilical surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 40

Inclusion Criteria

ASA grade 1-3 physical status.

Exclusion Criteria

Hypersensitivity to local anesthetics, absolute contraindications to spinal anesthesia that is patients refusal, any bleeding diathesis patients, local site infection,relative contraindications like severe hypotension, obstructive cardiomyopathies, any spinal deformity, spinal cord injnury.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parameter that will be used to evaluate effect of addition of tramadol in post-operative analgesic effect of drug is VISUAL ANALOG SCALE (VAS) SCORE. VAS score will be assessed every 40 minute interval till 6 hours post-operatively for the first analgesic requirement.	Parameter that will be used to evaluate effect of addition of tramadol in post-operative analgesic effect of drug is VISUAL ANALOG SCALE (VAS) SCORE. VAS score will be assessed every 40 minute interval till 6 hours post-operatively for the first analgesic requirement.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability. PARAMETERS that will be assessed are HYPOTENSION, BRADYCARDIA, ARRYTHMIAS, DESATURATION and side effects like NAUSEA, VOMITTING, PRURITUS, SHIVERING and URINARY RETENTION in patients undergoing gynecological surgeries. THIS PARAMETERS WILL BE ASSESSED INTRA-OPERATIVELY THROUGHT THE SURGERY.	Hemodynamic stability. PARAMETERS that will be assessed are HYPOTENSION, BRADYCARDIA, ARRYTHMIAS, DESATURATION and side effects like NAUSEA, VOMITTING, PRURITUS, SHIVERING and URINARY RETENTION in patients undergoing gynecological surgeries. THIS PARAMETERS WILL BE ASSESSED INTRA-OPERATIVELY THROUGHT THE SURGERY.

Trial Locations

Locations (1): Pramukh Swami Medical College, Shree Krishna hospital, Karamsad
🇮🇳
Anand, GUJARAT, India
Pramukh Swami Medical College, Shree Krishna hospital, Karamsad
🇮🇳Anand, GUJARAT, India
Dr Madhavi Chaudhari
Principal investigator
9427084963
madhavic@charutarhealth.org