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Comparison of two techniques namely,an abdominal muscle block on both sides of the incision wound and a local skin wound block using a local anesthetic named Bupivacaine for providing effective pain relief after surgery in emergency surgeries involving midline abdominal incision.

Not yet recruiting
Conditions
Peritonitis, unspecified,
Registration Number
CTRI/2019/01/017134
Lead Sponsor
Jawaharlal Institiute of Postgrduate Medical Education and Research
Brief Summary

Post-operative pain has the potential for significant adverse effects on the physiology and can also drown the patient into psychological suffering. The source and degree of nociceptive stimulation differ among individuals and surgeries and hence an effective analgesic approach could be encouraged for pain relief. Thoracic epidural analgesia is invaluable in providing excellent post-operative analgesia and aid in early recovery. But in many patients undergoing emergency surgeries initiation of thoracic epidural anaesthesia is not feasible due to various reasons like difficulties in patient positioning secondary to pain, haemodynamic disturbance or coagulation abnormalities. Epidural analgesia also has some disadvantages of predisposing to hypotension and motor weakness during the postoperative period.There is a growing interest in bilateral rectus sheath block in patients who underwent emergency laparotomy with midline incision as part of multimodal therapy in the management of post-operative pain.There are not much Randomized Controlled Trials comparing the efficacy of bilateral rectus sheath block with that of wound infilteration with local anesthetic for post-operative analgesia in emergency abdominal surgeries with midline incision.

With the current emphasis on fast-tracking after surgery and considering the fact that opioids contribute to nausea, vomiting, and ileus; it is necessary to have a viable alternative for pain management. Bilateral rectus sheath blocks provide a feasible option for effective pain management in these scenario. Successful management of post-operative pain with bilateral rectus sheath  blocks has been reported.



The study hypothesis is that Bilateral rectus sheath block with Bupivacaine is more efficacious in reducing the post-operative pain score when compared to wound infiltration with Bupivacaine in emergency midline laparotomy surgeries during the first 24 hours

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

All individuals with 18-70years of age, undergoing emergency midline (both supra and infra umbilical) laparotomy surgeries belonging to American Society of Anaesthesiologist’s category 1 to 3 in JIPMER.

Exclusion Criteria
  • i.Patients requiring ventilator support.
  • ii.Patients having coagulopathy or bleeding disorders.
  • iv.Patients having local abdominal wound infections.
  • v.Pregnant women vi.Allergy to local anesthetics vii.Patients not willing for the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare the analgesic effect in the post-operative period through bilateral rectus sheath block with Bupivacaine and local infiltration with Bupivacaine by using the Visual Analogue Scale (VAS)Time in hours.Visual Analogue Scale (VAS) is assessed at 1,4,8,12,24 hours after surgery to detect any pain in both bilateral rectus sheath block and local infilteration technique.
Secondary Outcome Measures
NameTimeMethod
To compare the morphine consumption in the post-operative period between the two groups.Time in minutes/hours.Cumulative morphine consumption in milligrams in the first 24 hours is noted in the post-opearative period according to the requirement in both the groups under study.
Time to requisition of first analgesic.Time in minutes/hours.Time required for first analgesic for the patient is noted in the post-opeartive period according to the need of the patient in both the groups.
Incidence of post-operative nausea,vomiting.Number in numericals.The number of episodes of nausea and vomiting in the first 24 hours post-operative period is assessed using a PONV Impact Scale Score which consists of two quessionaire and adding the numerical number corresponding to the response to both the questions.
To compare the Heart rate,Blood pressure,Saturation and Respiratory rate in the two groups in the postoperative period.Time in minutes/hours.Baseline Heart rate in beats per minute,Blood pressure in millimeters of mercury,Saturation in percentage and Respiratory rate per minute is noted before surgery and after extubation and also every 4th hourly till 12 hours and then at 24 hours.
Patient satisfaction of post-operative analgesia in the first 24 hours.Number in numericals.patient satisfaction of analgesia is assessed in the post-opeartive period using LIKERTS Scale. 1-Very dissatisfied 2-dissatisfied 3-unsure

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research

🇮🇳

Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Postgraduate Medical Education and Research
🇮🇳Pondicherry, PONDICHERRY, India
Dr Akshay LH
Principal investigator
9585522595
aakshaylh@gmail.com

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