Comparative Study of Two Different Techniques to Perform TAP-blocks

NCT02571439 | Completed Phase 4 Results

• 1 other identifier: IRB 2014-08-05
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

POSTOPERATIVE PAIN

Keywords

TAP block, post-cesarean analgesia

Outcome Measures

Primary Outcomes (1)

• Time Taken to Perform the Block

  Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.

  The time taken to perform the block in the operating room is measured, upto 60 minutes

Secondary Outcomes (5)

• Time From Delivery of Neonate to Ready to Exit Operating Room

  Time measures will be recorded in the operating room, upto 6 hours

• Severity of Postoperative Pain at Rest

  4 hours after surgery

• Severity of Postoperative Pain at Rest

  8 hours after surgery

• Severity of Postoperative Pain at Rest

  24 hours after surgery

• Severity of Postoperative Pain at Rest

  48 hours after surgery

Other Outcomes (4)

• Total Narcotic Consumption

  24 hours after surgery

• Sedation

  up to 24 hours after surgery

• Number of Participants With Postoperative Nausea/Vomiting

  up to 24 hours after surgery

Study Arms (2)

Surgical TAP block

EXPERIMENTAL

surgeon administered intraoperative TAP block using 0.5% ropivacaine

Procedure: Surgical TAP block; Drug: 0.5% ropivacaine

Conventional TAP block

ACTIVE COMPARATOR

Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine

Procedure: Conventional TAP block; Drug: 0.5% ropivacaine

Interventions

Surgical TAP block PROCEDURE

surgeon administered TAP block

Surgical TAP block

Conventional TAP block PROCEDURE

Anesthesiologist administered TAP block

Conventional TAP block

0.5% ropivacaine DRUG

20ml of 0.5% ropivacaine is used to perform the TAP block

Also known as: Naropin

Conventional TAP block; Surgical TAP block

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• We will recruit women undergoing scheduled cesarean delivery under neuraxial anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Personnel in OR could not be blinded due to nature of study. Personnel providing postop care and collecting postop data were blinded. Our study was not powered to explore the secondary outcomes; a larger study is needed to confirm those findings.

Results Point of Contact

• Title: Dr Kalpana Tyagaraj
• Organization: Maimonides Medical Center

KTyagaraj@maimonidesmed.org

7182836000

Study Officials

• Kalpana Tyagaraj, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: October 8, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 3, 2018
• Results First Posted: August 3, 2018

Record last verified: 2018-08

Locations

US (1)