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Bupivacaine local infiltration at trocar insertion sites after gynecologic laparoscopic surgery: A randomized, double-blind, placebo-controlled clinical trial

Bupivacaine local infiltration at trocar insertion sites after gynecologic laparoscopic surgery: A randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210904001
Enrollment
80
Registered
2021-09-04
Start date
2021-09-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bupivacaine local infiltration at trocar insertion sites after gynecologic laparoscopic surgery control pain decrease pain score than saline Gynecologic Laparoscopic Surgery, postoperative pain, bupivacaine

Interventions

0.5% bupivacaine 10ml infiltration at port site before closed skin at port entry site in gynecologic laparoscopic surgery ( at umbilical port 4 ml other port 2 ml *3 sites),Normal saline 10ml infiltr
Experimental Drug,Placebo Comparator Drug
Bupivacaine infiltration ,Saline infiltration

Sponsors

Obstetrics gynecologic department
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Female who has gynecologic laparoscopic surgery with 4-port entry 2. Can listening and reading Thai language 3. Thai nationality 4. No history of bupivacaine allergy or local anesthetic. Allergy 5. No psychiatric disorder 6. No history of medication for control pain in 1 week before 7. Accepted to volunteer in this research project

Exclusion criteria

Exclusion criteria: 1. Female who has gynecologic laparoscopic surgery with port entry less than 4 ports site 2. Who have change laparoscopic surgery convert to laparotomy 3. Volunteers who can leave from journal

Design outcomes

Primary

MeasureTime frame
Postoperative pain At 2,4,8,12,24 hours after intervention Record pain score 0-10 In postoperative at 2,4,8,12,24 hours after surgery ( abdominal pariatal pain, abdominal visceral pain, left shoulder pain , right shoulder pain

Secondary

MeasureTime frame
Number of opioid use 72 hour after surgery Number of patient who have opioid use and amount of opioid in patients use ,Adverse effect of bupivacaine 72 hours af surgery Such as : skin rash, seizure, Nausea, Headache, Dizziness, Slow heart rate, Blurred vision ,hearing loss

Countries

Thailand

Contacts

Public ContactNetpreeya Nakngam

Buddhachinaraj phitsanulok hospital

preaprea_riiz@hotmail.com0882809049

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026