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Multimodal Analgesia for Cholecystectomy

The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04788654
Enrollment
60
Registered
2021-03-09
Start date
2021-03-17
Completion date
2021-07-31
Last updated
2023-10-06

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

Conditions

Laparoscopic Cholecystectomy

Keywords

postoperative pain

Brief summary

It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.

Interventions

PROCEDURESaline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.

DRUGCelebrex, acetaminophen, and dexamethasone

Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

1. Recent gastric ulcer disease 2. Hepatic or renal insufficiency 3. Opioid dependency 4. Coagulopathy 5. Pre-existing neurologic or anatomic deficits in the lower extremities 6. Severe psychiatric illness 7. pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Area under curve of postoperative pain for 24 hourAt postoperative 24 hourArea under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).

Secondary

MeasureTime frameDescription
Postoperative pain score,At postoperative 0, 2, 6, and 24 hourPostoperative pain score: postoperative pain score will be measured at postoperative 0, 2, 6, and 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).
Analgesic requirements,At postoperative 24 hourAnalgesic requirements will be measured at postoperative 24 hour. Total dose of tramadol, ketorolac, and pethidine will be assessed at postoperative 24 hour.
Sleep qualityAt postoperative 24 hourSleep quality will be measured using sleep quality questionnare at postoperative 24 hour. using sleep quality questionnare.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026