Postoperative Pain
Conditions
Keywords
adnexal mass, laparoscopy, removal route, postoperative pain
Brief summary
In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.
Detailed description
Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available.
Interventions
PROCEDURETransumbilical removal of specimen via laparoscopy
Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
PROCEDURELateral transabdominal removal of specimen via laparoscopy
Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The use of analgesics for postoperative pain | Change in 24 hours after surgery | The total amount of analgesics used measured by use of Oxycodone (mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea | Change in 24 hours after surgery | Nausea after the procedure: Visual Analog Score (VAS) for nausea, to measure quality of nausea. 10-point VAS score for nausea \[(0-10), 0 indicating no nausea and 10 indicating unbearable nausea. at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10) |
| Vomiting | Change in 24 hours after surgery | Vomiting after the procedure: Visual Analog Score (VAS) for vomiting to measure quality of vomiting. 10-point VAS score for vomiting \[(0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting\] at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10) |
| Length of hospital stay in hours | Up to one week | Length of hospital stay measured from the end of the operation until discharge (hours) |
| Quality of life | At baseline and 6 months after the surgery | A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group) |
| Complications | The first six months after the surgical intervention | Frequency of complications. Values are given as n (%) and eventual complications are specified |
| Costs | During the surgery | Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros) |
| Surgeon perception of both techniques | After one month after the operation | A questionnaire one month after operation of opinion of surgeons on preferred route of specimen removal (% of respondents in the group) |
| Length of need of postoperative pain medication | Change in one month after surgery | A questionnaire of pain medication needed postoperatively. (Days) |
| Postoperative pain scores | Change in 24 hours after surgery | Visual Analog Score (VAS) for pain to measure quality of pain. 10-point VAS score for pain \[(0-10), 0 indicating no pain and 10 indicating unbearable pain\] at 1, 3, 6, 12 and 24 h (hour) after surgery (Units on a Scale; 0-10) |
| Cosmetic outcome | At baseline and 6 months after the surgery | A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group) |
Countries
Finland
Outcome results
None listed