Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.

Study Description:

Background:

The field of laparoscopic and robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients can be suitable for laparoscopic surgery compared to open surgery, because of the less trauma and inflammatory response to the surgery and thereby faster recovery.

Extreme positioning of the patients as well as painful stimuli during and after surgery could still stress the circulatory response of the patient causing a mismatch in oxygen delivery and needs. Perioperative pain relief could be even more important during this type of surgery, when painful stimuli are more unpredictable.

This Study:

In this study painful stimuli during surgery are registered by the NOL pain monitor (Nociception Level) and intraoperative dosing of analgesia (remifentanil) is guided by the NOL index. NOL < 25 is accepted during surgery.

All patients receive preoperative: Acetaminophen 1g, Meclozinehydrocloride 25mg.

• Total opioid consumption during and after surgery is compared between three groups of patients receiving: Patients receiving Fentanyl intrathecal need 6 hours postoperative observation and patients receiving morphine intrathecal need 10 hours observation time.

1. Preoperative: Oxycodone orally
2. Preoperative: Intrathecal Fentanyl
3. Preoperative Intrathecal Morphine. Preoperative pain assessment of the patients are Postoperative Pain from Assessment of Pain Associated with Venous Cannulation (1-10)

Anesthesia: Induction of anesthesia with propofol, remifentanil and rocuronium. During surgery: Sevoflurane + remifentanil. BIS 35-50. NOL <25. Monitoring: EKG, Blood pressure, BIS (Bispectral index) and NOL. Before wake up: Parecoxib 40mg iv. Ondansetron 4mg iv. Group 1: Morphine 0,05mg/kg iv. 10 min before waking up: 1ug/kg fentanyl to all patients. Time of surgery is also registered and volume of bleeding as well.

After surgery:

NRS (Numeric Pain Scores (0-10) are registered in the PAVU when the patient is at the PACU, when leaving the PACU as well as the maximum pain score postoperative.

Total dose of opioids converted to morphine equivalents are compared between the groups as well as the pain scores and time in the PACU.

Power calculation show a need for 63 patients to receive 80% power to show a difference in morphine-equivalents between groups of 1 mgs. (p<0,05).