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Comparison of three methods of pain relief in patients undergoing gall bladder surgery

Phase 4
Recruiting
Conditions
patients scheduled to undergo laparoscopic cholecystectomy
Registration Number
CTRI/2013/03/003493
Brief Summary

Laparoscopic cholecystectomy is routinely performed on day care basis for treatment of symptomatic cholelithiasis.Pain in laparoscopic cholecystectomy may be substantial and  arises predominantly from skin incision sites, creation of pneumoperitoneum and trauma created by cholecystectomy itself.The pain induced by laparoscopic cholecystectomy has a considerable visceral component owing to surgical handling and diaphragmatic irritation and may contribute to shoulder tip pain in one third of the patients.

Adequate postoperative analgesia in the post operative period leads to reduction in the stress response and morbidity while facilitating rehabilitation and accelerating recovery at the same time. Regional analgesic techniques provide patient comfort by reducing the pain intensity and avoiding the side effects of systemic analgesics.

Various methods have been used to alleviate pain after laparoscopic cholecystectomy which include nonsteroidal anti-inflammatory drugs (NSAIDs), opioids,  intraperitoneal infiltration of local anesthetic, thoracic epidural block, multimodal analgesia and infiltration of local anesthetic at port site.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Transversus  abdominis plane (TAP) block is a regional technique that provides pain relief by   blocking abdominal neural afferents through the introduction of local anesthetic into the neurofascial plane between the internal oblique and the transversus abdominis muscles thereby reducing the postoperative pain of abdominal surgeries. There are no studies presently available in literature comparing the efficacy of USG TAP block, portsite infiltration and intraperitoneal infiltration of the local anaesthetic for providing adequate post operative analgesia in patients undergoing laparoscopic cholecystectomy, hence we intend to compare the effect of 0.375% ropivacaine (3mg/kg) to provide post operative analgesia when administered either at the portsite, intraperitoneal or in TAP block in patients undergoing laparoscopic cholecystectomy

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
150
Inclusion Criteria

•ASA physical status I-II •Age 18-65 yrs •Body weight 50-75 kg of either sex ( BMI.

Exclusion Criteria

•History of relevant drug allergy •Age 18yrs or 65yrs •History of psychiatric illness , substance abuse , or medical therapies resulting in tolerance to opioids •Acute cholecystitis or pancreatitis •Severe cardiovascular , respiratory ,metabolic or neurological disease •Surgery requiring postoperative intra-abdominal drainage •Pregnancy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare and evaluate post operative pain scores after administration of US guided TAP block, port site infiltration and intraperitoneal instillation with ropivacaine in laparoscopic cholecystectomy.To compare and evaluate post operative pain scores after administration of US guided TAP block, port site infiltration and intraperitoneal instillation with ropivacaine in laparoscopic cholecystectomy in the immediate post operative period and then at 10 min, 30 min, 60 min, 4 hours, 8 hrs, 12 hrs and 24 hrs.
Secondary Outcome Measures
NameTimeMethod
1.To compare and evaluate post operative nausea and vomiting scores.2. To calculate the total amount of rescue analgesic used in all the patients.

Trial Locations

Locations (1)

Goverment Medical college and hospital

🇮🇳

Chandigarh, CHANDIGARH, India

Goverment Medical college and hospital
🇮🇳Chandigarh, CHANDIGARH, India
Dr Richa Saroa
Principal investigator
919646121513
richajayant@rediffmail.com

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