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

Rajavithi Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain Score

Treatments: Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03259243

RAJLAPGYNE

Details and patient eligibility

About

To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery

Full description

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

Enrollment: 100 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS

Treatment:

Drug: Bupivacaine Hydrochloride

Preincision Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride

Preclosure bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride

Bupivacaine group

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride