None listed
Conditions
Brief summary
Laparoscopic (‘keyhole’) surgery is used to perform many different types of gynaecological surgery. These include diagnosis of reasons why pregnancy has not been possible, diagnosis of abdominal pain, and treatment of endometriosis (which is painful, abnormal tissue in the abdomen (belly). It also includes procedures using a robot to aid surgery, and removal of organs or abnormal growths. There are several causes of pain after this sort of surgery. One cause of pain is local damage to the wall of the abdomen due to the tubes that run into the abdomen that make keyhole surgery possible. For a long time surgeons have used local anaesthetic in small amounts that is injected into the holes or ‘port sites’ where these tubes are inserted. More recently a different way of giving local anaesthetic has become popular. This is called the ‘TAP block’ which stands for “transversus abdominis plane” block. The name simply means that it is injected alongside the transversus muscle in the wall of the abdomen. Anaesthetists tend to use an ultrasound probe to take a picture and place this at the right depth, but for surgeons to place it laparoscopically while they operate is also a recognised technique. This study will investigate whether the infiltration method or TAP method of giving local anaesthetic is more effective by measuring pain on a scale of 1 to 10 just after surgery and 24 hours after surgery. The surgeon will be instructed to perform either the TAP block or infiltration based on the patient’s randomisation. The anaesthetist, recovery staff, and patient will be blinded, so unaware of what the patient has received. The surgeon, who is not blinded, will not be involved in any measurement of pain scores. Patients undergoing any type of gynaecological keyhole surgery will be accepted. TAP blocks have been looked at in many trials now. There are some aspects to this trial which would be novel in combination and would add to our knowledge base. The surgeon would be giving the block. This approach has been used relatively rarely. By doing away with the need to keep the patient asleep while the anaesthetic performs the block and gets set up with an ultrasound machine, the block can be performed with minimal delay to the list. This is a ‘real-world’ trial which compares two commonly-used techniques, rather than comparing TAP blocks to injection of saline, which means that a convincing result would guide the choice to use one or the other. This trial is not restricted to some subgroup of gynaecology patient; it would look at a cross-section of any day-case or inpatient laparoscopic gynaecology population.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Women undergoing gynaecological laparoscopy over 18 years of age.
Exclusion criteria
Known allergy or intolerance to study drugs including sulfa drugs, local anaesthetic drugs, morphine, oxycodone or fentanyl.