Comparision of ANALGESIC EFFECACY OF ULTRASOUND GUIDED ABDOMINAL BLOCK WITH EPIDURAL ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL GYNAECOLOGICAL PROCEDURES

Phase 4

Active, not recruiting

• Conditions: patients undergoing lower abdominal gynecological surgeries

• Registration Number: CTRI/2015/05/005803
• Lead Sponsor: Post Graduate Institue of Medical education research

Brief Summary

Totalabdominal hysterectomy is a routinely performed major surgery that results insubstantial post-operative pain and discomfort. Poorly controlled acute pain after abdominal hysterectomy is associatedwith increased incidence of post-operative complications like atelectasis,pneumonia, delirium, myocardial ischemia, prolonged hospital stay and anincreased likelihood of chronic pain. Forpostoperative pain relief, non-opioid drugs, patient controlled intravenousstrong opioids or central neuroaxial blockade are introduced in a stepwisefashion in response to reported pain intensity, usually combining two or moreagents to provide adequate relief whilst minimizing adverse effects from anyindividual analgesic. Peripheral nerve blockade is an alternative method ofproviding pain relief, which offers excellent selective analgesia across a widerange of surgical procedures. Epiduralanalgesia is the gold standard analgesic technique. It is associated with lowervisual analogue pain scores (VAS) and higher patient satisfaction. However   undesirable effects like motor blockade andurinary retention with increasing doses of local anaesthetics have beenreported. A failure rate ranging from 17-37% has also been reported with theuse of this technique.Opioids delivered usingpatient controlled analgesia is another modality available. Though patients maybe comfortable at rest, some may experience significant pain on movement.Adverse effects like sedation, nausea, vomiting, pruritis and respiratorydepression are frequently associated with this technique.  Renal toxicity, general bleeding risks are associated with use of nonopioids like non steroidal anti-inflammatory drugs.

Abdominalwall incision contributes to a significant component of pain experienced bypatients after abdominal surgery. A promisingnovel approach to post-operative analgesia is to block the sensory nerve supplyto the anterior abdominal wall using transversus abdominis plane block. TAPblock involves infiltration of local anaesthetic into a plane between theinternal oblique and transverse abdominis muscle, thus blocking the sensorynerves before their infiltration of the muscles of anterior abdominal wall.Theanalgesic efficacy of TAP block has been demonstrated in different surgicalprocedures.  However, the analgesic efficacy ofsonographically guided TAP block has not been compared with epidural analgesiapreviously.

Wehypothesize that co-administration of sonographically guided TAP block  with continuous epidural infusion of localanesthetics as part of a multimodal analgesic technique would result insuperior postoperative analgesia (lower pain scores) and better patientsatisfaction following total abdominal hysterectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-30
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

ASA class I or II undergoing elective total abdominal hysterectomies.

Exclusion Criteria

Contraindications to epidural anesthesia (coagulopathy, local infection),History of relevant drug allergy, Uncooperative patient, Patients with BMI > 35,History of chronic pain, History of previous surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest	to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest immediately in the post operative period and then at 30min, 1,2, 4,6,12,24,and 48hrs.

Secondary Outcome Measures

Name	Time	Method
Bedside pulmonary function tests using Wrights respirometer
Total epidural local anaesthetic consumption in the 1st 48 hours postoperatively.	upto 48 hrs

Trial Locations

Locations (1)

Post graduate institute of medical education and research; 🇮🇳 Chandigarh, CHANDIGARH, India

Post graduate institute of medical education and research

🇮🇳Chandigarh, CHANDIGARH, India

Ajay

Principal investigator

7087009510

nscjk2006@gmail.com