Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy

The Catholic University of Korea

Status: Completed

Conditions: Postoperative Pain; Uterine Disease

Treatments: Device: single-port laparoscopic hysterectomy(single port trochar); Device: multi-port laparoscopic hysterectomy(multi port trochar)

Study type: Interventional

Funder types: Other

Identifiers

NCT02390804

DC14EISI0026

Details and patient eligibility

About

The objective of this study is to compare postoperative pain between single-port access total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and postoperative pain and operative outcomes were examined.

Full description

The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Incluson Criteria

1. Subject has benign uterine disease
2. Subject needs total hysterectomy.
3. Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3).

Exclusion Criteria:

1. suspicion of malignancy
2. the need for simultaneous interventions such as prolapse repair
3. uterine size greater than 18 weeks of gestation
4. ongoing peritoneal dialysis
5. diseases associated with abdominal pain such as pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

single-port laparoscopic hysterectomy

Experimental group

Description:

total laparoscopic hysterectomy via transumbilical single port

Treatment:

Device: single-port laparoscopic hysterectomy(single port trochar)

multi-port laparoscopic hysterectomy

Active Comparator group

Description:

total laparoscopic hysterectomy via multi-port (3 port)

Treatment:

Device: multi-port laparoscopic hysterectomy(multi port trochar)