Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Study Overview
=================
Brief Summary
-----------------
Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.

Official Title
-----------------
Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: Ultrasound Guided Erector Spinae Plane Block
* Drug: Intra thecal morphine.
* Drug: General anesthesia using intravenous fentanyl (1µgm/kg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) 25 to 35kg/m². American Society of Anesthesiologist (ASA) physical status I or II. Exclusion Criteria: patient's refusal Altered mental status Known allergy to study drugs (bupivacaine or morphine) Local infection at site of puncture. Known case with any pulmonary disease Known case with Obstructive sleep apnea (OSA) Coagulopathy and /or thrombocytopenia Chronic pain Severe hepatic or kidney impairment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G1 Group: (Erector Spinae Plane Block (ESPB) Group)<br> | Procedure: Ultrasound Guided Erector Spinae Plane Block<br>* General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%<br>|
| Active Comparator: G2 Group: (Intra thecal morphine (ITM) Group)<br> | Drug: Intra thecal morphine.<br>* General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine<br>|
| Other: G3 Group: (Control Group)<br> | Drug: General anesthesia using intravenous fentanyl (1µgm/kg)<br>* Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for requirement of first rescue analgesic (min) | The time for requirement of first rescue analgesic (min) | 24 hours postoperatively |