Abdominal surgeries and postoperative pain relief

Not yet recruiting

• Conditions: Other and unspecified intestinal obstruction,

• Registration Number: CTRI/2018/11/016455
• Lead Sponsor: Dr S N Medical College and attached Hospital Jodhpur

Brief Summary

This prospective, randomized study will be conducted in the Department of Anaesthesiology, Dr. S. N. Medical College and attached group of hospitals, Jodhpur, after approval from institutional ethical committee. The patients will be randomly selected from the patients posted for elective laprotomy, under general anaesthesia after confirming all inclusion and exclusion criteria. A written informed consent will be taken from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure in perioperative course of anaesthesia.  All selected patients will be undergo a routine pre-anaesthetic check-up (PAC), including explanation of numeric rating scale (NRS) pain scale (0-10, where 0 stands for no pain and 10 stands for worst imaginable pain) for post-operative pain assessment. All the patients will be kept nil per oral as per the fasting guidelines. All patients will be premedicated with tab alprazolam 0.5 mg orally night before the surgery. 

In the operative room, identification of patient, fasting status, consent and PAC will be confirmed. After reassuring the patient, standard ASA monitoring will be applied. Base line heart rate (HR), non- invasive systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MAP), respiratory rate (RR), and peripheral oxygen saturation (SpO2) will be recorded. Continuous electrocardiographic (ECG) monitoring will be done. Peripheral i.v.cannulation will be done by using 18G cannula in the upper limb and lactated ringer’s solution 10 ml/kg will be started.

The general anaesthesia will be induced with injection fentanyl (1.5 -2μg/kg) and propofol (1.5 - 2.0 mg/kg). The endotracheal intubation will be facilitated by using muscle relaxant atracurium besylate (0.5mg/kg) after confirming adequacy of ventilation and loss of consciousness. The airway will be secured with appropriate size of endotracheal tube. The anaesthesia will be maintained with air oxygen (50:50), isoflurane and atracurium besylate. Supplemental analgesia will be providing with injection fentanyl (1 μg/kg) when rise in HR or MAP more than 20% of base line values. Continuous monitoring of HR, NIBP, SpO2 and end tidal carbon-dioxide (EtCO2) will be done throughout intra operative period and recorded every 15 min. The EtCO2 will be maintained between 35-40 mm Hg. The number of doses and total amount of supplement analgesia intra operative with fentanyl will be recorded for comparison between two groups. Fifteen min before surgery completion ondansetron 8 mg i.v. given. After completion of surgery bilateral rectus sheath block will be given according to allocated group.

Rectus sheath block will be given  under all aseptic precaution as per study group, with real-time ultra-sonographic guidance (13-6 MHz Linear Array Transducer; Sonosite M-Turboâ„¢, Bothell, WA, USA) using a 22G (0.70 mm × 50 mm) via an in-plane approach to the rectus sheath.The probe will be placed horizontally over the rectus sheath at T10 level on either side of the midline.The posterior rectus muscle sheath and the fascia transversalis will be identified as twin hyperechoic lines. A Stimuplex®A insulated needle (B. Braun, Melsungen, Germany) connected to an infusion line was introduced in plane with the US probe in a medial to lateral direction at an angle of approximately 45° to the skin plane. Under real-time US guidance, the needle will be gradually advanced posterior to the rectus muscle and above the underlying rectus sheath toward its lateral edge, approaching the rectus sheath with the blunt side of the bevel, lateral to the deep inferior epigastric artery to avoid damaging it with the needle. Following negative aspiration testing, a bolus of 1 mL of 21 mL drug solution will be slowly injected through the needle. If intramuscular spread of the LA occurred, the needle will be advanced until the rectus muscle will be separated from the posterior rectus sheath by hydrodissection.  At this point, the remaining anesthetic solution will be deposited under US guidance. The same procedure will be repeated on the opposite side.

After performing the block, residual neuromuscular blockade will be reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg i.v. and the trachea will be extubated when the patient is fully awake and breathing adequately. The patients will be shifted to the post anaesthesia recovery unit (PACU) for further management. The total duration of the surgery will be also recorded. Post operatively patients will be given morphine 3 mg i.v. as rescue analgesia, if NRS ≥4.  HR, NIBP, SpO2, RR and NRS score will be recorded at 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 h after the surgery. Time to first rescue analgesia as well as the total doses of morphine used in first 24 h will be recorded. Any side effects like nausea, vomiting, respiratory depression, hypotension, sign and symptoms of local anaesthetic toxicity will be recorded and treated accordingly. Nausea lasting more than 10 min or vomiting will be treated with ondansetron 4mg i.v.The patient’s satisfaction score will be noted.

The following characteristics of the block will be observed postoperatively: **1.** **Duration of analgesia:** Duration of analgesia will be defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic. The rescue analgesic regime morphine3 mgi.v. slowly as analgesic whenever NRS ≥ 4 or on request.

**2. Pain assessment:** The numerical rating scale (NRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line which contains 11-point numeric scale ranges from ’0’ representing one pain extreme (e.g. “no painâ€) to ’10’ representing the other pain extreme (e.g. “pain as bad as you can imagineâ€or “worst pain imaginableâ€). NRS for pain will be assessed during rest (NRS-R) and movement (NRS-M) at predefined intervals at 0, 2, 4, 6, 8, 10, 12, 15, 18, 21 and 24 h postoperatively.

3. **Total rescue analgesic consumption:** The total dose of morphine used in initial 24 h.

4. **Postoperative side effects or complications:** Local anesthetic toxicity, nausea, vomiting, pruritus, drowsiness, convulsions etc.

5. **Hemodynamic and respiratory changes:** Bradycardia (pulse <50 beats/min), hypotension (reduction of MAP >20% of baseline), respiratory depression (RR ≤8 breaths/minute or SpO2< 90%).

**6**. **Patient’s satisfaction score:**    4 = excellent, 3 = good, 2 = fair, 1 = poor.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Age between 18 to 60 yr 2.
• Body weight 40 to 80 kg 3.
• Patients belong to American Society of Anaesthesiologists (ASA) grade I and II 4.

Exclusion Criteria

• Patients refusal 2.
• Local infection at the block site 3.
• Coagulopathy 4.
• Morbid obesity or body mass index (BMI >40) 5.
• Allergy to local anaesthetics 6.
• Any chronic systemic illness 7.
• Pre-existing peripheral neuropathy or neurological deficits 9.
• Psychiatric illness 10.
• Patients on anticoagulants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the duration of analgesia (time to first rescue analgesia after administration of block)	24 Hours

Secondary Outcome Measures

Name	Time	Method
1.To compare post-operative rescue analgesic (morphine) consumption in first 24 h	2.To compare NRS Pain scores at rest and on cough in first 24 h

Trial Locations

Locations (1)

Mathura Das Mathur Hospital; 🇮🇳 Jodhpur, RAJASTHAN, India

Mathura Das Mathur Hospital

🇮🇳Jodhpur, RAJASTHAN, India

DrGeeta Singariya

Principal investigator

9414803554

geetamanojkamal@gmail.com