Different Maneuvers for Reducing Post-laparoscopic Pain
关键词
抽象
描述
Laparoscopic surgery is becoming more popular due to smaller incision, faster recovery, less postoperative pain, and earlier returns to normal activity . However post-laparoscopic shoulder and upper abdominal pain may upset the patient more than the pain at the incision site. The incidence of shoulder pain after laparoscopic gynecological surgery varies from 35% to 80% and could be so severe at 24 hours after laparoscopic hysterectomy as well.
The mechanism of post laparoscopic shoulder and abdominal pain attributes to the insufflated co2 in the abdominal cavity and become entrapped between the liver and the right diaphragm causing irritation of the phrenic nerve, diaphragm and referred pain in the C4 dermatome. On the other hand, the prolonged exposure to residual CO2 dissolution leads to intra-abdominal acidosis and consequent peritoneal irritation and abdominal pain.
As long as the retention of CO2 is the key factor in the laparoscopy-induced shoulder and abdominal pain, many strategies have been evolved to alleviate different types of pain in patients undergoing laparoscopic surgeries such as usage of low-pressure pneumoperitoneum (8-10 mmHg) that result in reducing the intensity of postoperative pain in comparison to standard high-pressure pneumoperitoneum (12-15 mmHg). Although this low pressure may impair visualization and jeopardize the surgeon's comfort during surgery, this method is proven to be safe and feasible.
One of the maneuvers that have been proposed is an intraperitoneal normal saline infusion (IPS) that increases intraperitoneal pressure to enhance the removal of residual CO2, as well as offers a physiologic buffer system to wash out excess CO2.
Pulmonary recruitment maneuvers (PRM) has also a potential beneficial effect on alleviating post-laparoscopic pain by mechanically increasing intraperitoneal pressure to accelerate the elimination of residual CO2.
Because these variable techniques are mediated through different mechanisms, the investigators hypothesize that combination of two different maneuvers may be ideal and more effective in reducing post-laparoscopic shoulder and abdominal pain than any single or standard maneuver in patients undergoing laparoscopic gynecologic surgeries.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 07/12/2020 |
| 提交的预估入学人数: | 07/15/2020 |
| 首次发布: | 07/16/2020 |
| 上次提交的更新: | 07/15/2020 |
| 最近更新发布: | 07/16/2020 |
| 实际学习开始日期: | 07/12/2020 |
| 预计主要完成日期: | 10/31/2020 |
| 预计完成日期: | 11/30/2020 |
状况或疾病
干预/治疗
Procedure: Group C
Procedure: Group L
Procedure: Group LR
Procedure: Group LS
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Group C high intra-abdominal pressure | Procedure: Group C laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site. |
| Active Comparator: Group L low intra-abdominal pressure | Procedure: Group L laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure. |
| Active Comparator: Group LR low intra-abdominal pressure with pulmonary recruitment maneuver group | Procedure: Group LR the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consist of five manual pulmonary inflations at a maximum pressure of 60 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity. |
| Active Comparator: Group LS low intra-abdominal pressure with intraperitoneal saline infusion group | Procedure: Group LS the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight) |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patient acceptance. - BMI ≤35 kg/m2. - ASA I and ASA II. - Scheduled for elective laparoscopic gynecologic surgeries for benign lesions under general anesthesia. Exclusion Criteria: - Patients with pre-existing chronic pain disorders. - Patients on opioid or sedative use. - Psychological and mental disorders. - Severe hypertensive, cardiac, hepatic and renal patients. |
结果
主要结果指标
1. changes in assessment of shoulder, abdominal and incisional pain [at 1, 2, 4, 6, 12, 24 and 48 hours postoperatively]
次要成果指标
1. Time of first request of analgesia [within 24 hour postoperative]
2. Total rescue analgesic requirement [during the first postoperative 48 hours]
