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Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05214157
Acronym
Pain
Enrollment
804
Registered
2022-01-28
Start date
2020-03-20
Completion date
2022-01-08
Last updated
2022-01-28

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

Conditions

Acute Post-operative Pain, Cholecystectomy, Laparoscopic, Pain Assessment Pain Intensity, Pain Intensity

Brief summary

evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.

Detailed description

Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.

Interventions

sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients who were having symptoms consistent with biliary colic, * had ultrasound evidence of gall stones, * classified as American Society of Anesthesiology (ASA) I and II * ages ranging from 18 to 65 years

Exclusion criteria

* Patients who refused to give consent, * pregnant, * had a history of drug abuse, * had CBD stones, * acute cholecystitis, * acute pancreatitis, * previous abdominal surgery, * history of peritonitis, * had carcinoma of the gall bladder Patients who were converted to open surgery, * patients who required placement of drains * patients with intraoperative complications (CBD injury or liver bed bleeding).

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain intensity6 - 24 hoursseverity by visual analogue scale

Secondary

MeasureTime frameDescription
hospital stay1-5 daysnumbers of days

Countries

Egypt

Outcome results

None listed

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