A Study to Determine the Effectiveness of Ultrasound Guided TAP Block in Pain Relief After Caesarean Scetion

Completed

Conditions: Pregnant mothers undergoing lower segment caesarean section

Registration Number: CTRI/2017/03/008194

Lead Sponsor: TATA Motors Hospital

Brief Summary: Caesarean section is a major surgical procedure with signifcant pain and discomfort. An ideal analgesic technique must provide good pain relief and should be safe to both the mother and the child.

Apart from safety and comfort, good post-operative pain control facilitates early ambulation; this would decrease the risk of thromboembolic complications which are increased in pregnancy. Mothers also need to be pain free to care for their newborn and breastfeed them effectively. The conventional methods of analgesia use opioids administered through systemic and neuraxial routes. However, unwanted effects like sedation,nausea and vomiting, pruritus and occasionally respiratory depression remain a major issue with opioids. In addition,secretion into breast milk is a unique concern in this population. Drugs like Non-Steroidal Anti Inflammatory Drugs(NSAID) and Paracetamol can only supplement other modes of analgesia and are rarely sufficient on their own.Given these issues, peripheral nerve block techniques like TAP block were introduced as an effective component of multimodal analgesia after Caesarean delivery. These techniques were not only found to reduce pain successfully but also found to prevent the problems associated with the use of systemic opioids or central neuraxial blocks .

The Transversus Abdominis Plane (TAP) is a neurofascial plane lying between the internal oblique in front and the transversus abdominis behind; it contains the thoraco-lumbar nerves originating from T6 to L1 which supply the anterior abdominal wall.By introducing local anesthetics into this plane, it is possible to block the sensory nerves of the anterior abdominal wall before they exit this plane and pierce the muscles to innervate the entire abdominal wall. TAP block has been described as an effective component of multimodal analgesic regimen for post Caesarean delivery pain relief .

100 women undergoing LSCS under a standard spinal anesthetic technique were randomized into treatment and control groups. Both the groups received standard post-operative analgesia ( 75mg IV Diclofenac twice daily and an additional combined dose of 30mg Pentazocine &25mg Promethazine intramuscularly SOS. The treatment arm of the study in addition received a USG guided TAP block with 25ml of 0.3%Ropivacaine on each side at the end of the surgery. Each patient was assessed on arrival in the Post Anesthesia Care Unit (PACU) and at intervals of 2, 4, 6, 8, 10,12, 18 & 24 hours after surgery. The primary outcome was the time request to first dose of analgesia. The secondary outcome measures were the number of supplemental analgesic requirements, nausea, sedation & pruritis scores, features of respiratory depression, measures of patient satisfaction, complications of the block and adverse effects of local anaesthetics.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Pregnant mothers undergoing lower segment caesarean section who had given informed consent for inclusion in the study.

Exclusion Criteria

1.A history of drug allergy or local anaesthetic toxicity 2.
BMI >35kg/m2 and pregnancy weight <50kg (to limit maximum Ropivacaine dose to 3mg/kg) 3.
Comtraindications to regional anaesthesia ( bleeding diathesis, infection at the site of block and peripheral neuropathy , severe anxiety ) 4.
Mothers with pregnancy induced complications like pre-eclampsia and eclampsia, patients who have intra-operative complications like post-partum haemorrhage.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time duration to first request of analgesia	24 hours post caesarean section

Secondary Outcome Measures

Name	Time	Method
Total number of supplemental analgesic doses required in 24 hours, nausea score, pruritus score, sedation score, the presence/absence of respiratory depression, complications of TAP block, systemic effects of local anaesthetics and patient satisfaction score.	24 hours post caesarean section

Trial Locations

Locations (1): TATA Motors Hospital
🇮🇳
Singhbhum, JHARKHAND, India
TATA Motors Hospital
🇮🇳Singhbhum, JHARKHAND, India
Priyanka Jain
Principal investigator
9031156109
drpriyankajain@hotmail.com