Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery

Study Overview
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Brief Summary
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To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery

Detailed Description
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Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera. Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain

Official Title
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Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial

Conditions
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Postoperative Pain Score

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who undergoing gynecologic laparoscopic surgery Patient who agrees to participate in this study Patient able to speak and understand Thai Patient able to complete the questionnaire Exclusion Criteria: Patient with history of allergy in any kind anesthetic drug Patient who pregnant Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery Patient whom the surgery is withhold or canceled Patient whom the surgery is converted to laparotomy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS | Drug: Bupivacaine Hydrochloride<br>* 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection<br>* Other names: 0.5% Marcaine;|
| Experimental: Preincision Bupivacaine<br>0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS | Drug: Bupivacaine Hydrochloride<br>* 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection<br>* Other names: 0.5% Marcaine;|
| Experimental: Preclosure bupivacaine<br>0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine | Drug: Bupivacaine Hydrochloride<br>* 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection<br>* Other names: 0.5% Marcaine;|
| Experimental: Bupivacaine group<br>0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine | Drug: Bupivacaine Hydrochloride<br>* 0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection<br>* Other names: 0.5% Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain after surgery | Postoperative pain score in intervention and placebo groups | 24-48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Among of pethidine use | Among of pethidine use to reduced postoperative pain | within 48 hours | 
| Duration of hospital stay | Duration of hospital stay after surgery | within 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy