Phase 4
N=41
Comparative Study of Two Different Techniques to Perform TAP-blocks
POSTOPERATIVE PAIN
Bottom Line
View on ClinicalTrials.gov: NCT02571439 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Time Taken to Perform the Block — 2.4; 12.1 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Surgical TAP block (Procedure); Conventional TAP block (Procedure); 0.5% ropivacaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Maimonides Medical Center
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Taken to Perform the Block |
2.4; 12.1 | <0.001 sig |
| SECONDARY Time From Delivery of Neonate to Ready to Exit Operating Room |
55.3; 77.9 | <0.001 sig |
| SECONDARY Severity of Postoperative Pain at Rest |
2; 0 | 0.13 |
| SECONDARY Severity of Postoperative Pain at Rest |
2; 0 | 0.13 |
| SECONDARY Severity of Postoperative Pain at Rest |
2; 0 | 0.13 |
| SECONDARY Severity of Postoperative Pain at Rest |
2; 0 | 0.13 |
Summary
The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space will block these nerves and prevent pain following c-section. The investigators will compare two different approaches to injecting the local anesthetic in this space. Conventionally, the block is done after surgery is completed and the abdomen is closed. The anesthesiologist introduces a needle through the abdominal wall skin under ultrasound guidance to reach the TAP space and the drug is injected. Since the TAP layer is one of the deeper layers of the abdominal (belly) wall and is closer to the inside of the abdomen than to the outside (skin), injecting from the inner aspect of the abdominal wall during the surgery is easier and quicker to perform than the conventional block and does not require ultrasound guidance as there is no risk of injury to abdominal organs like the liver.
With this research the investigators attempt to prove that surgically administered TAP blocks take 25% less time to perform compared to the conventionally administered TAP block for post cesarean section pain relief. Surgical TAP blocks are also more cost-effective as in addition to reduced OR time, they are safer and do not require skilled operator and specialized equipment. Secondary outcomes will include total time spent in the Operating room, presence and severity of postoperative pain, time to first request for pain medication, total postoperative narcotic consumption in 48 hours after surgery and side effects.
Eligibility Criteria
Inclusion Criteria
- We will recruit women undergoing scheduled cesarean delivery under neuraxial anesthesia
Exclusion Criteria
- Age less than 18 years
- We will limit recruitment to women able to speak atleast one of the following languages: English, Spanish, Chinese, Russian
- Chronic pain syndrome
- Opioid dependence
- Allergy to local anesthetic
- Vertical skin incision
- Sepsis at the site of injection
- Converted to general anesthesia
- Any complicated procedures including blood loss more than 2000ml and duration of surgery more than 2 hours.
Data sourced from ClinicalTrials.gov (NCT02571439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.