Pain, Postoperative
Conditions
Brief summary
Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (\<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.
Detailed description
We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.
Interventions
PROCEDUREIntraabdominal pressure
Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 15 years 2. Elective procedure of laparoscopic cholecystectomy 3. Sign to Inform consent
Exclusion criteria
1. Emergency surgery 2. Concomitant other procedure performed 3. Deny to participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder tip pain | 48 hours | The shoulder tip pain was assessed by the investigator during postoperative period unfil 48 hours. The measurement of the outcome, the investigator would ask the participant by the clinical record form and questionnair. The answer of the questionnaire is presence or absence of the shoulder pain or pain around the shoulder and scapular region. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of intra-abdominal pressure | Immediately after surgery | The change of intra-abminal pressure was measure by two parameters. Firstly, the adjustment of the pressure during the operation was recorded by the questionnaire. The answer of the questionnaire is the presence or absence of the intra-abdominal pressure change. Secondly, the maximum intra-abdominal pressure which is the highest pressure used during the operation, is measure by the level of the pressure appearing in the laparoscopic station by mmHg unit. |
| Difficulty of the operation | Immediately after surgery | The difficulty level of the operation which evaluated by the surgeons. The measurement of this outcome by the questionnaire. |
Countries
Thailand
Contacts
Primary ContactThanida Janbavonkij, M.D.
Backup ContactNarongsak Rungsakulkij, M.D.
Outcome results
None listed