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Effect of extraperitoneal instillation of 0.5% bupivacaine for postoperative analgesia in laparoscopic hernioplasty: a randomized controlled trial

Effect of extraperitoneal instillation of 0.5% bupivacaine for postoperative analgesia in laparoscopic hernioplasty: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231021003
Enrollment
100
Registered
2023-10-21
Start date
2023-11-12
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

Patients that receive an operation laparoscopic totally extraperitoneal hernioplasty. inguinal hernia, bupivacaine, laparoscopic

Interventions

0.5 % Bupivacaine 10 ml instillation to preperitoneal space in laparoscopic total extraperitoneal hernioplasty ,Normal saline solution 10 ml instillation to preperitoneal space in laparoscopic total e
Experimental Drug,Placebo Comparator Drug
0.5% Bupivacaine 10 ml ,Normal saline solution 10 ml

Sponsors

Research department, Faculty of medicine, Siriraj hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 18 years of age or more 2. A person who receives a surgery, laparoscopic totally extraperitoneal hernioplasty at Siriraj Hospital from October 1, 2023 to March 31, 2025. 3. Participants can listen and understand Thai language and can give a consent for research. 4. The person who receives a single operation at the time of surgery 5. The patient has a ASA (American socity anesthesiologyist) physical status I - III.

Exclusion criteria

Exclusion criteria: 1. Incarcerated inguinal hernia or strangulated inguinal hernia 2. Giant inguinal hernia(larger than half of thigh) 3. History of drug allergy that use in research : paracetamol, morphine, fentanyl, and etoricoxib 4. Restrictions in using research-related drugs include; moderate to severe kidney disease, a history of cardiovascular disease, congestive heart failure, history of coronary artery bypass graft, asthma, cirrhosis 5. Unable to communicate or to tell the degree of pain. 6. Recurrent inguinal hernia 7. Bilateral inguinal hernia that surgery both sides in the same operation. 8. Weight less than 35 kgs at time of admission

Design outcomes

Primary

MeasureTime frame
Pain score 1 hr Numeric rating scale

Secondary

MeasureTime frame
Pain score 30 min, 90 min, 120 min, 4 hrs, 6hrs, 8 hrs, 10 hrs, 12 hrs, 24 hrs Numeric rating scale,Time to first analgesia When pain score upto 4 points Time after surgery,Time to first sit, stand and walk when patient start to sit, stand, and walk time,Morphine use in 24 hrs 24 hours Morphine milligram equivalent,Length of hospital stay when patient ready to discharge Hours

Countries

Thailand

Contacts

Public ContactNaraporn Prayoonwiwat

Siriraj institutional review board

siethics@mahidol.ac.th024192667

Outcome results

None listed

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