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CompletedNCT03259243Updated Oct 22, 2020

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

A Phase 4 interventional study of Bupivacaine Hydrochloride in Postoperative Pain Score, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Rajavithi Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Postoperative Pain Score

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Keywords

  • Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    placebo group

    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

  • Experimental
    Preincision Bupivacaine

    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

  • Experimental
    Preclosure bupivacaine

    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

  • Experimental
    Bupivacaine group

    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

Interventions

  • DrugBupivacaine Hydrochloride

    0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection

    Also known as: 0.5% Marcaine

05

What researchers measure

Primary outcomes

  1. Postoperative pain after surgery

    Postoperative pain score in intervention and placebo groups

    Time frame: 24-48 hours after surgery

Secondary outcomes

  1. Among of pethidine use

    Among of pethidine use to reduced postoperative pain

    Time frame: within 48 hours

  2. Duration of hospital stay

    Duration of hospital stay after surgery

    Time frame: within 7 days

06

Study locations

1 site
  • Waetasleem Chema
    Bangkok, 10400, Thailand
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03259243
Lead sponsor
Rajavithi Hospital
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Apr 1, 2017
Primary completion
Oct 30, 2017
Completion
Jan 31, 2018
Last update
Oct 22, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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